Colorimetry, Salicylate

FDA product code DKJ · 29 cleared devices

Class 2 Clinical Toxicology

Regulation: 21 CFR 862.3830
Review panel: TX
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1981-11-24 – 2010-05-19

DKJ 2010-05-19

ADVIA CHEMISTRY SALICYLATE REAGENT

Applicant Siemens Healthcare Diagnostics

K number K093939

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DKJ 2004-12-27

SALICYLATE-SL ASSAY

Applicant Diagnostic Chemicals , Ltd.

K number K042329

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DKJ 2002-07-11

SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

Applicant Bayer Diagnostics Corp.

K number K020794

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DKJ 2002-02-15

SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR

Applicant Beckman Coulter, Inc.

K number K014173

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DKJ 2001-08-13

EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL

Applicant Syva Co.

K number K011878

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DKJ 1998-06-29

SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40

Applicant Diagnostic Chemicals , Ltd.

K number K981872

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DKJ 1998-03-02

SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71

Applicant Diagnostic Chemicals , Ltd.

K number K980032

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DKJ 1997-04-25

PARAMAX SALICYLATE REAGENT

Applicant Dade Intl., Inc.

K number K964715

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DKJ 1996-04-29

SALICYLATE ASSAY

Applicant Diagnostic Reagents, Inc.

K number K961131

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DKJ 1995-08-08

AXSYM SALICYLATE

Applicant Abbott Laboratories

K number K951290

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DKJ 1995-01-25

ABUSCREEN ONLINE(R) CALIBRATORS

Applicant Roche Diagnostic Systems, Inc.

K number K946000

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DKJ 1990-11-09

DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD

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

K number K904301

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DKJ 1990-07-16

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI)

Applicant Eastman Kodak Company

K number K902356

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DKJ 1988-06-24

GDS ENZYMATIC SALICYLATE REAGENT

Applicant Gds Technology, LLC

K number K882038

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DKJ 1987-10-29

EASY-TEST SALICYLATE (SAL) #16691

Applicant Em Diagnostic Systems, Inc.

K number K873425

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DKJ 1987-08-28

EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93

Applicant Em Diagnostic Systems, Inc.

K number K872321

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DKJ 1987-07-09

EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95

Applicant Em Diagnostic Systems, Inc.

K number K872330

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DKJ 1987-02-20

SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K870336

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DKJ 1986-05-23

SALICYLATE REAGENT SET

Applicant Sterling Diagnostics, Inc.

K number K861615

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DKJ 1985-05-29

GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER

Applicant Advanced Biomedical Methods, Inc.

K number K852027

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DKJ 1984-11-27

TDX SALICYLATE

Applicant Abbott Laboratories

K number K844070

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DKJ 1984-10-22

SALICYLATE ASSAY KIT

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K842158

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DKJ 1984-09-07

SALICYLATE TEST

Applicant Sclavo, Inc.

K number K843180

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DKJ 1984-03-23

DETERMIN. OF SALICYLATE IN SERUM/PLAST

Applicant Sigma Chemical Co.

K number K840243

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DKJ 1983-10-28

PARAMAX SALICYLATE REAGENT

Applicant American Dade

K number K833003

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DKJ 1983-07-07

SALICYLATE ASSAY KIT

Applicant Quantimetrix Corp.

K number K831336

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DKJ 1983-01-14

TOXI-LAB RAPID SCREEN

Applicant Marion Laboratories, Inc.

K number K823523

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DKJ 1982-03-25

SALICYLATES

Applicant Bio-Analytics Laboratories, Inc.

K number K813431

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DKJ 1981-11-24

SALICYLATE STAT-PAK

Applicant Clin Tech Diagnostics Corp.

K number K813185

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