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Anti-Sm Antibody, Antigen And Control

FDA product code LKP · 27 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5100
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1984-06-25 – 2021-07-14

LKP 2021-07-14

EliA SmDP-S

Applicant Phadia AB

K number K202067

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LKP 2018-12-24

EliA SmDP Immunoassay

Applicant Phadia AB

K number K183007

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LKP 2013-04-17

QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,

Applicant Inova Diagnostics, Inc.

K number K123593

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LKP 2005-10-07

THERATEST EL-ANA PROFILES

Applicant Theratest Laboratories, Inc.

K number K051066

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LKP 2004-12-08

VARELISA SM ANTIBODIES, MODEL 18296

Applicant Sweden Diagnostics (Germany) GmbH

K number K042629

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LKP 2003-01-15

LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115

Applicant Bio-Rad

K number K024219

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LKP 2002-07-29

FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST

Applicant Fred Hutchinson Cancer Research Center

K number K013263

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LKP 2000-05-09

RHIGENE MESACUP2 TEST- SM

Applicant Rhigene, Inc.

K number K000755

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LKP 2000-03-17

VARELISA SM ANTIBODIES

Applicant Pharmacia & Upjohn Co.

K number K000312

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LKP 1999-04-28

AUTOSTAT II ANTI-SM ELISA

Applicant Cogent Diagnotics , Ltd.

K number K990625

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LKP 1998-12-22

LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208

Applicant Bio-Rad

K number K984479

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LKP 1998-11-18

THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO

Applicant Zeus Scientific, Inc.

K number K983420

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LKP 1998-06-15

SERAQUEST ANTI-SM

Applicant Quest Intl., Inc.

K number K980540

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LKP 1998-05-12

SERAQUEST ANTI-SM/RNP

Applicant Quest Intl., Inc.

K number K980811

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LKP 1996-05-08

ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY

Applicant Orgentec

K number K954830

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LKP 1996-03-22

HYTEC AUTOIMMUNE KITS (SM)

Applicant Hycor Biomedical, Inc.

K number K954896

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LKP 1994-04-20

ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT

Applicant Helix Diagnostics, Inc.

K number K940510

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LKP 1993-05-11

SYNELISA SM ABS/RNP-SM ABS

Applicant Elias U.S.A., Inc.

K number K930141

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LKP 1991-05-07

IMMUNOWELL SM ANTIBODY TEST

Applicant General Biometrics, Inc.

K number K911851

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LKP 1991-05-07

IMMUNOWELL RNP/SM ANTIBODY TEST

Applicant General Biometrics, Inc.

K number K911848

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LKP 1990-12-07

DIASTAT ANTI-SM/RNP

Applicant Shield Diagnostics, Ltd.

K number K905192

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LKP 1990-12-07

DIASTAT ANTI-SM

Applicant Shield Diagnostics, Ltd.

K number K905191

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LKP 1989-11-06

RHEUMELISA ASSAY FOR SM AUTOANTIBODIES

Applicant Lipogen, Inc.

K number K895996

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LKP 1988-05-16

WESBLOT RNP-SM TEST

Applicant American Bionetics, Inc.

K number K881379

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LKP 1988-04-06

SM ANTIBODY TEST KIT

Applicant Lipogen, Inc.

K number K880254

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LKP 1987-11-04

IMMUSTRIP(TM) SM ELISA TEST SYSTEM

Applicant Immunomedics, Inc.

K number K873741

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LKP 1984-06-25

ENZYMATIC ACETAMINOPHEN ASSAY

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K841930

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