Multi-Analyte Controls, All Kinds (Assayed)

FDA product code JJY · 659 cleared devices

Class 1 Clinical Chemistry

Regulation: 21 CFR 862.1660
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-11-05 – 2017-03-31

JJY 1988-05-27

MULTI-FUNCTION BLOOD GAS CONTROL

Applicant Bionostics, Inc.

K number K880447

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JJY 1988-05-16

URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II

Applicant Fisher Scientific Co., LLC

K number K881275

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JJY 1988-03-03

LYPHOCHEK SPINAL FLUID CONTROL (HUMAN)

Applicant Bio-Rad

K number K880494

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JJY 1988-03-01

DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL

Applicant Baxter Healthcare Corp

K number K880175

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JJY 1988-02-18

LYPHOCHEK WHOLE BLOOD CONTROL

Applicant Bio-Rad

K number K874731

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JJY 1988-01-21

LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II

Applicant Bio-Rad

K number K874280

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JJY 1988-01-07

REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM

Applicant Biotrol, USA, Inc.

K number K874809

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JJY 1988-01-05

REFERENCE ASSAYED CHEMISTRY CONTROL SERUM

Applicant Biotrol, USA, Inc.

K number K874810

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JJY 1988-01-05

DC-TROL LEVEL 1 OR 2

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K874772

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JJY 1987-12-29

LIQUI-SERA SPINAL FLUID CONTROL

Applicant Biodiagnostic Intl

K number K874459

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JJY 1987-11-23

PRECINORM L

Applicant Boehringer Mannheim Corp.

K number K874230

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JJY 1987-10-20

A-QC CLINICAL CHEMISTRY CONTROL

Applicant Arden Medical Systems, Inc.

K number K873611

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JJY 1987-08-26

BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM

Applicant Biotrol, USA, Inc.

K number K872785

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JJY 1987-08-26

BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL

Applicant Biotrol, USA, Inc.

K number K872777

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JJY 1987-08-05

LIPID CONTROL SERUM

Applicant Biological Industries

K number K872376

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JJY 1987-07-09

DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR

Applicant American Dade

K number K871977

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JJY 1987-07-07

UNASSAYED CONTROL SERUM, NORMAL (BOVINE)

Applicant Vanguard Diagnostic Systems

K number K872304

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JJY 1987-07-07

UNASSAYED CONTROL SERUM, ABNORMAL (BOVINE)

Applicant Vanguard Diagnostic Systems

K number K872303

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JJY 1987-07-06

LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II

Applicant Bio-Rad

K number K872227

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JJY 1987-05-21

QM2/QM300 CONTROL A PACK

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

K number K871342

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JJY 1987-05-06

CANTROL HDL CHOLESTROL CONTROLS LEVELS I AND II

Applicant Canyon Diagnostics, Inc.

K number K871537

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JJY 1987-04-06

SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN)

Applicant Fisher Scientific Co., LLC

K number K871058

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JJY 1987-04-06

LIQUID CHEMISTRY CONTROL, LEVEL I

Applicant U. S. Diagnostics, Inc.

K number K870684

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JJY 1987-04-06

LIQUID CHEMISTRY CONTROL, LEVEL II

Applicant U. S. Diagnostics, Inc.

K number K870683

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JJY 1987-02-20

DOCUMENT(TM) MULTI-ANALYTE LINEARITY TEST SET

Applicant Casco Standards

K number K870252

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JJY 1987-01-13

CHEMTROL(TM)

Applicant G.B.F. Industries, Inc.

K number K862565

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JJY 1987-01-09

TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS

Applicant Nms Pharmaceuticals, Inc.

K number K861202

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JJY 1986-11-24

LIQUI-SERA COMBO LIGAND/TDM CONTROLS

Applicant Biodiagnostic Intl

K number K863849

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JJY 1986-11-24

MULTI-ANALYTE LIN-TROL

Applicant Sigma Diagnostics, Inc.

K number K863751

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JJY 1986-10-29

SERACON CT REFERENCE

Applicant Bhp Diagnostix, Inc.

K number K863648

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JJY 1986-10-07

ABNORMAL SPINAL FLUID CONTROL

Applicant Ciba Corning Diagnostics Corp.

K number K863745

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JJY 1986-09-16

QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL

Applicant Quantimetrix Corp.

K number K861420

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JJY 1986-09-15

THERAPEUTIC DRUG MONITORING CONTROL SET

Applicant American Monitor Corp.

K number K862963

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JJY 1986-08-04

CHEMTROL(TM)

Applicant G.B.F. Industries, Inc.

K number K862587

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JJY 1986-08-04

CHEMVARION(TM)

Applicant G.B.F. Industries, Inc.

K number K862586

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JJY 1986-08-04

UTAK-STABBS TOXICOLOGY CONTROL

Applicant Utak Laboratories, Inc.

K number K862420

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JJY 1986-08-04

GAS-TRAK

Applicant United Diagnostics, Inc.

K number K862278

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JJY 1986-08-04

LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL

Applicant Bio-Rad

K number K862185

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JJY 1986-07-02

GILFORD UNIQUAL ABNORMAL CONTROL SERUM/ASSAYED

Applicant Ciba Corning Diagnostics Corp.

K number K860999

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JJY 1986-07-01

SOMAS LIQUID URINE CONTROL

Applicant Somas Medical Industries, Inc.

K number K862179

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JJY 1986-06-17

MULTI-4 CO-OXIMETER CONTROL

Applicant Allied Instrumentation Laboratory

K number K861901

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JJY 1986-05-29

STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III

Applicant American Dade

K number K860906

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JJY 1986-05-23

IRON PROCEDURE

Applicant Data Medical Associates, Inc.

K number K861603

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JJY 1986-05-23

CONTROL SERA LEVEL VALUES (MG/DL)

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K861567

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JJY 1986-05-23

THERACHEM-PLUS, TRI-LEVEL TDC (TM)

Applicant Fisher Scientific Co., LLC

K number K861185

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JJY 1986-05-23

QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID

Applicant Quantimetrix Corp.

K number K860942

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JJY 1986-04-28

QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID

Applicant Quantimetrix Medical Industries

K number K861448

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JJY 1986-04-07

GILFORD UNIQUAL NORMAL CONTROL SERUM - ASSAYED

Applicant Ciba Corning Diagnostics Corp.

K number K861068

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JJY 1986-04-03

GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED

Applicant Ciba Corning Diagnostics Corp.

K number K861000

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JJY 1986-04-03

GILFORD UNIQUAL ABNORMAL CONTROL SERUM/UNASSAYED

Applicant Ciba Corning Diagnostics Corp.

K number K860998

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JJY 1986-04-03

PRECINORM IM AND PRECIPATH IM

Applicant Boehringer Mannheim Corp.

K number K860970

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JJY 1986-03-17

BOVINE CHEMISTRY CONTROL I.X AND II.X

Applicant American Dade

K number K860355

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JJY 1986-03-17

CHEMISTRY CONTROL N & A

Applicant Integrated Medical Systems Int'L., Inc.

K number K855036

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JJY 1986-03-17

CALIBRATION REFERENCE I & II

Applicant Integrated Medical Systems Int'L., Inc.

K number K855035

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JJY 1986-01-17

CANTROL ELECTROPHORESIS CONTROL

Applicant Canyon Diagnostics, Inc.

K number K854931

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JJY 1986-01-13

RANGE-CHEK

Applicant American Monitor Corp.

K number K854789

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JJY 1986-01-07

CRITIC - SF, ASSAYED

Applicant Dimension Diagnostics

K number K854967

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JJY 1985-12-23

CRITIC C LEVEL I & II

Applicant Dimension Diagnostics

K number K853943

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JJY 1985-10-25

ACCURACY

Applicant Columbia Diagnostics, Inc.

K number K854119

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JJY 1985-10-04

QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL

Applicant Quantimetrix Corp.

K number K853931

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JJY 1985-10-04

LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE)

Applicant Biodiagnostic Intl

K number K853906

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JJY 1985-08-02

DC LIQUITROL LEVEL 1 & 2

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K852753

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JJY 1985-07-15

QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)

Applicant Amf Biological and Diagnostics Co.

K number K852418

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JJY 1985-07-15

SPINAL FLUID CONTROL

Applicant Irvine Scientific

K number K851820

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JJY 1985-07-12

DC-LIP, CATALOGUE NUMBER SE-020

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K852594

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JJY 1985-05-31

COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY

Applicant Coulter Electronics, Inc.

K number K851942

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JJY 1985-04-12

DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO

Applicant American Dade

K number K850574

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JJY 1985-04-10

DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H

Applicant American Dade

K number K850575

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JJY 1985-03-05

PRECINORM H & PRECIPATH H

Applicant Boehringer Mannheim Corp.

K number K850017

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JJY 1985-03-01

IMA-TROL IMMUNOASSAY CONTROL

Applicant Dimension Diagnostics

K number K844848

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JJY 1985-02-27

ULTROSER G

Applicant Lkb Instruments, Inc.

K number K844413

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JJY 1985-02-06

GELMAN TRIPHOR CONTROL

Applicant Gelman Sciences, Inc.

K number K850202

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JJY 1985-02-06

PARAGON TRICHECK ELECTROPHORESIS CONTROL

Applicant Beckman Instruments, Inc.

K number K844996

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JJY 1985-01-08

UROL-QUAL

Applicant Dimension Diagnostics

K number K844760

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JJY 1985-01-08

LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN

Applicant Bio-Rad

K number K844125

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JJY 1984-11-27

GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3

Applicant United Diagnostics, Inc.

K number K844018

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JJY 1984-11-27

STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3

Applicant United Diagnostics, Inc.

K number K843986

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JJY 1984-09-28

QUALIFY I & II AMER. MONITOR 2009 & 2010

Applicant American Monitor Corp.

K number K843611

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JJY 1984-08-29

ALLERGENTICS TOTAL IGE/THEOPHYLLINE

Applicant Allergenetics

K number K842970

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JJY 1984-07-06

KODAK EKTACHEM CONTROL

Applicant Eastman Kodak Company

K number K841884

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JJY 1984-06-22

NOVA STAT CONTROL LEVELS 1/2/3

Applicant Nova Biomedical Corp.

K number K841452

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JJY 1984-04-17

BIOTIS ABNORMAL CLINICAL CHEM SERUM-

Applicant Otisville Biotech, Inc.

K number K840458

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JJY 1984-04-13

NORMAL CLINICAL CHEM. CONTROL SERUM-

Applicant Otisville Biotech, Inc.

K number K840457

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JJY 1984-03-23

ORTHO BI-LEVEL RECEPTOR CONTROL

Applicant Ortho Diagnostic Systems, Inc.

K number K834064

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JJY 1984-01-13

OMNI-FAL I & II

Applicant American Monitor Corp.

K number K833009

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JJY 1984-01-04

TITANGEL HIGH RESOLUTION CONTROL

Applicant Helena Laboratories

K number K833639

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JJY 1983-12-08

VENTREZYME EIA CONTROLS-IMMUNOASSAY

Applicant Ventrex Laboratories, Inc.

K number K833423

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JJY 1983-12-08

NORMAL URINE CONTROL

Applicant Biosan Laboratories, Inc.

K number K833192

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JJY 1983-12-08

ABNORMAL URINE CONTROL

Applicant Biosan Laboratories, Inc.

K number K833191

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JJY 1983-07-07

ELECTROPHORESIS CONTROLS-3 IN 1

Applicant Corning Medical & Scientific

K number K831263

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JJY 1983-02-18

BIOCELL SPINAL FLUID CONTROL

Applicant Biocell Laboratories, Inc.

K number K830179

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JJY 1983-02-07

IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS

Applicant American Dade

K number K823352

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JJY 1983-01-28