Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

System, Test, Rheumatoid Factor

FDA product code DHR · 143 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5775
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-03 – 2020-05-20

DHR 2020-05-20

K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)

Applicant Kamiya Biomedical Company

K number K192727

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DHR 2019-04-17

QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents

Applicant Inova Diagnostics, Inc.

K number K190088

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DHR 2018-12-18

EliA RF IgM Immunoassay

Applicant Phadia AB

K number K182747

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DHR 2017-05-03

Optilite Rheumatoid Factor Kit

Applicant The Binding Site Group , Ltd.

K number K162263

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DHR 2016-12-07

Rheumatoid Factor (RF) Kit for use on SPAPLUS

Applicant The Binding Site Group , Ltd.

K number K160070

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DHR 2011-09-30

RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM

Applicant Phadia US, Inc.

K number K102673

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DHR 2010-10-27

ORGENTEC RHEUMATOID FACTOR EIA

Applicant Orgentec Diagnostika GmbH

K number K100499

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DHR 2009-10-29

IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM

Applicant Sqi Diagnostics Systems

K number K083080

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DHR 2007-08-08

N LATEX RF KIT

Applicant Dade Behring, Inc.

K number K071247

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DHR 2006-06-06

OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.

Applicant Olympus America, Inc.

K number K060201

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DHR 2004-11-05

MININEPH HUMAN RHEUMATOID FACTOR KIT

Applicant The Binding Site

K number K041891

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DHR 2004-09-20

VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS

Applicant Ortho-Clinical Diagnostics, Inc.

K number K041863

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DHR 2004-02-27

ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K033802

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DHR 2003-09-10

MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM

Applicant Roche Diagnostics Corp.

K number K032535

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DHR 2003-01-15

RHEUMATOID FACTOR (RF)

Applicant Abbott Laboratories

K number K024067

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DHR 2002-09-09

WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET

Applicant Wako Chemicals USA, Inc.

K number K020972

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DHR 2002-07-09

DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM

Applicant Diamedix Corp.

K number K021394

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DHR 2000-09-05

TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM

Applicant Roche Diagnostics Corp.

K number K002609

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DHR 2000-04-05

COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II

Applicant Roche Diagnostics Corp.

K number K000534

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DHR 2000-03-03

AUTOSTAT II RHEUMATOID FACTOR IGA ELISA

Applicant Cogent Diagnotics , Ltd.

K number K993557

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DHR 2000-02-03

AUTOSTAT II RHEUMATOID FACTOR IGM ELISA

Applicant Cogent Diagnotics , Ltd.

K number K994338

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DHR 2000-01-11

MDI RF TEST

Applicant Micro Detect, Inc.

K number K993843

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DHR 1999-12-06

AUTOSTAT II RHEUMATOID FACTOR IGG ELISA

Applicant Cogent Diagnotics , Ltd.

K number K993304

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DHR 1999-06-10

K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET

Applicant Kamiya Biomedical Co.

K number K991467

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DHR 1999-06-09

K-ASSAY RHEUMATOID FACTOR

Applicant Kamiya Biomedical Co.

K number K991409

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DHR 1999-04-07

ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01

Applicant Bio-Rad

K number K990587

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DHR 1999-03-08

RF

Applicant Abbott Laboratories

K number K990035

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DHR 1999-01-25

RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS

Applicant Kamiya Biomedical Co.

K number K984045

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DHR 1998-11-18

THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL

Applicant Zeus Scientific, Inc.

K number K983418

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DHR 1998-11-04

QUANTA LITE RF IGA ELISA

Applicant Inova Diagnostics, Inc.

K number K983084

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DHR 1998-11-04

QUANTA LITE RF IGG ELISA

Applicant Inova Diagnostics, Inc.

K number K983083

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DHR 1998-06-15

COLOR-SLIDE RF

Applicant Seradyn, Inc.

K number K981496

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DHR 1998-03-06

DIAMEDIX IS-RF TEST SYSTEM

Applicant Diamedix Corp.

K number K974889

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DHR 1998-02-17

RAPET RF

Applicant Stanbio Laboratory

K number K974370

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DHR 1997-11-25

RHEUMACOL RHEUMATOID FACTOR TEST

Applicant Immunostics Inc.,

K number K972456

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DHR 1997-10-22

QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)

Applicant Instrumentation Laboratory CO

K number K973464

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DHR 1997-09-09

RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT

Applicant Randox Laboratories, Ltd.

K number K972220

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DHR 1997-06-27

ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT

Applicant Beckman Instruments, Inc.

K number K971602

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DHR 1997-06-20

QUANTA LITE RF IGM

Applicant Inova Diagnostics, Inc.

K number K971614

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DHR 1997-06-17

TINAQUANT RHEUMATOID FACTOR ASSAY

Applicant Boehringer Mannheim Corp.

K number K971379

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DHR 1997-06-03

SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR

Applicant Beckman Instruments, Inc.

K number K971788

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DHR 1997-04-17

RAICHEM RHEUMATOID FACTOR SPIA

Applicant Henage Diagnostics, Inc.

K number K970373

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DHR 1997-03-07

HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY

Applicant Hycor Biomedical, Inc.

K number K962729

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DHR 1996-12-16

THERATEST EL-RFSCR

Applicant Theratest Laboratories, Inc.

K number K962050

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DHR 1996-12-13

N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET

Applicant Kamiya Technology Services

K number K964418

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DHR 1996-12-13

N-ASSAY TIA RHEUMATOID FACTOR TEST KIT

Applicant Kamiya Technology Services

K number K964415

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DHR 1996-11-25

RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST

Applicant Teco Diagnostics

K number K962015

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DHR 1996-11-04

IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT

Applicant Beckman Instruments, Inc.

K number K963048

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DHR 1996-09-24

QUALITROL RF CONTROLS

Applicant Consolidated Technologies, Inc.

K number K961545

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DHR 1996-09-12

HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)

Applicant Hemagen Diagnostics, Inc.

K number K962836

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DHR 1996-06-26

RHEUMATOID FACTOR LATEX SLIDE TEST KIT

Applicant Randox Laboratories, Ltd.

K number K961169

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DHR 1996-06-04

LIQUICHEK RHEUMATOID FACTOR CONTROL

Applicant Bio-Rad

K number K960987

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DHR 1996-05-08

RF IGM ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K961277

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DHR 1996-04-19

RF-LATEX SEIKEN REAGENT SYSTEM

Applicant Globe Management Support, Inc.

K number K960703

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DHR 1995-12-26

HYTEC AUTOMIMMUNE KIT (RF)

Applicant Hycor Biomedical, Inc.

K number K954892

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DHR 1995-12-20

TEST, RHEUMATOID FACTOR

Applicant Polymedco, Inc.

K number K955086

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DHR 1995-08-24

OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT

Applicant Olympus America, Inc.

K number K953520

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DHR 1995-08-15

CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM

Applicant Shared Systems, Inc.

K number K953261

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DHR 1995-07-28

EL-RF/3 (IGM-IGG-IGA) KIT

Applicant Theratest Laboratories, Inc.

K number K941398

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DHR 1995-01-20

IGM RF EIA

Applicant Sigma Diagnostics, Inc.

K number K942908

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DHR 1994-10-20

N LATEX RF

Applicant Behring Diagnostics, Inc.

K number K942328

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DHR 1994-09-26

IGM RHEUMATOID FACTOR

Applicant Immco Diagnostics, Inc.

K number K942272

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DHR 1994-01-28

EL-RF TEST SYSTEM: EL-RF-IGM KIT

Applicant Theratest Laboratories, Inc.

K number K933712

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DHR 1993-08-23

EYE SPOT RF TEST

Applicant J & S Medical Assoc., Inc.

K number K932437

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DHR 1993-04-06

IMMUNO RA UNDILUTED

Applicant Immunostics Co., Inc.

K number K926569

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DHR 1992-12-07

RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST

Applicant Trinity Laboratories, Inc.

K number K915320

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DHR 1992-12-01

ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST

Applicant J.S. Medical Assoc.

K number K924036

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DHR 1992-10-06

LIQUICHEK RHEUMATOID FACTOR CONTROL

Applicant Bio-Rad

K number K923578

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DHR 1992-10-05

PULSE RF TEST

Applicant Pulse Scientific, Inc.

K number K923771

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DHR 1992-10-05

TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL

Applicant Simplicity Diagnostics, Inc.

K number K922725

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DHR 1992-09-25

ENCORE RHEUMATOID FACTOR EIA

Applicant Clark Laboratories, Inc.

K number K924056

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DHR 1992-07-28

WAKO AUTOKIT RF

Applicant Wako Chemicals USA, Inc.

K number K922151

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DHR 1992-03-30

RF STAT IGM TEST KIT

Applicant Biowhittaker Molecular Applications, Inc.

K number K920753

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DHR 1992-03-13

HEALTHTEST RHEUMATOID FACTOR ASSAY

Applicant Akers Research Corp.

K number K920220

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DHR 1992-03-02

TURBIQUANT

Applicant Behring Diagnostics, Inc.

K number K920124

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DHR 1991-05-31

RHEUMAGEN RF T-CONTROL

Applicant Biokit USA, Inc.

K number K904310

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DHR 1991-04-05

RHEUMAJET RF

Applicant Biokit USA, Inc.

K number K910539

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DHR 1990-10-29

CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST

Applicant Biotrax, Inc.

K number K904498

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DHR 1990-10-15

V-TREND TARGET RF TEST

Applicant Texas Immunology, Inc.

K number K904105

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DHR 1990-08-30

RAPITEX(R) RF NEW

Applicant Behring Diagnostics, Inc.

K number K903852

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DHR 1990-06-21

MODIFIED QM300 RHEUMATOID FACTOR TEST

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K902462

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DHR 1989-11-08

QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)

Applicant Biokit USA, Inc.

K number K896271

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DHR 1989-08-10

TECHNICON DPA-1 SYSTEM RF METHOD

Applicant Technicon Instruments Corp.

K number K894574

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DHR 1989-06-05

REAADS-RF TEST KIT-SEMIQUANTITATIVE

Applicant Biosearch Medical Products, Inc.

K number K892445

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DHR 1989-06-05

REAADS-RF TEST KIT-QUANTITATIVE

Applicant Biosearch Medical Products, Inc.

K number K892444

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DHR 1989-02-03

TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM

Applicant Unipath , Ltd.

K number K884180

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DHR 1988-09-07

QM300 CALIBRATOR E PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K883538

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DHR 1988-09-07

QM300 RHEUMATOID FACTOR ANTIGEN PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K883536

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DHR 1988-09-07

UBI MAGIWEL RF-IGM QUANTITATIVE

Applicant United Biotech, Inc.

K number K883355

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DHR 1988-02-10

RF CARD TEST & RF LIQUID TEST

Applicant Ampcor, Inc.

K number K880164

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DHR 1987-12-29

RF DIPSTICK TEST KIT

Applicant Lipogen, Inc.

K number K874151

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DHR 1987-11-27

REUMA TEST

Applicant Sclavo, Inc.

K number K873782

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DHR 1987-11-04

AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT

Applicant Amtec Diagnostics International, Inc.

K number K873064

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DHR 1987-05-06

RHEUMA-CHECK ENZYME IMMUNOASSAY TEST

Applicant Orion Diagnostica, Inc.

K number K871196

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DHR 1987-03-31

RF MICROASSAY

Applicant Diamedix Corp.

K number K871041

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DHR 1986-10-08

READS RF TEST KIT FOR IGM RHEUMATOID FACTOR

Applicant Biostar Medical Products, Inc.

K number K863238

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DHR 1986-04-22

SERATEST RF (HEMAGGLUTINATION) KIT

Applicant Hemagen Diagnostics, Inc.

K number K855221

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DHR 1986-02-06

DIESSE RF TEST KIT

Applicant Marvic Interpharma, Inc.

K number K854222

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DHR 1986-01-17

RA 80 EIKEN

Applicant Syn-Kit, Inc.

K number K854820

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DHR 1985-08-01

RF CARD TEST

Applicant Preco, Inc.

K number K853054

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