Atlas FDA

DKJ

29 FDA 510(k) clearances · Product code

56 daysmedian time to decision
145 days90th percentile
29clearances measured

FDA profile

Official device name
Colorimetry, Salicylate
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3830
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Adverse events (MAUDE)
1996: 1 · 2008: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ADVIA CHEMISTRY SALICYLATE REAGENT (K093939)Siemens Healthcare Diagnostics2010-05-19
SALICYLATE-SL ASSAY (K042329)Diagnostic Chemicals , Ltd.2004-12-27
SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K020794)Bayer Diagnostics Corp.2002-07-11
SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR (K014173)Beckman Coulter, Inc.2002-02-15
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL (K011878)Syva Co.2001-08-13
SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 (K981872)Diagnostic Chemicals , Ltd.1998-06-29
SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 (K980032)Diagnostic Chemicals , Ltd.1998-03-02
PARAMAX SALICYLATE REAGENT (K964715)Dade Intl., Inc.1997-04-25
SALICYLATE ASSAY (K961131)Diagnostic Reagents, Inc.1996-04-29
AXSYM SALICYLATE (K951290)Abbott Laboratories1995-08-08
ABUSCREEN ONLINE(R) CALIBRATORS (K946000)Roche Diagnostic Systems, Inc.1995-01-25
DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD (K904301)E.I. Dupont DE Nemours & Co., Inc.1990-11-09
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI) (K902356)Eastman Kodak Company1990-07-16
GDS ENZYMATIC SALICYLATE REAGENT (K882038)Gds Technology, LLC1988-06-24
EASY-TEST SALICYLATE (SAL) #16691 (K873425)Em Diagnostic Systems, Inc.1987-10-29
EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93 (K872321)Em Diagnostic Systems, Inc.1987-08-28
EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95 (K872330)Em Diagnostic Systems, Inc.1987-07-09
SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71 (K870336)Diagnostic Chemicals, Ltd. (Usa)1987-02-20
SALICYLATE REAGENT SET (K861615)Sterling Diagnostics, Inc.1986-05-23
GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER (K852027)Advanced Biomedical Methods, Inc.1985-05-29
TDX SALICYLATE (K844070)Abbott Laboratories1984-11-27
SALICYLATE ASSAY KIT (K842158)Diagnostic Chemicals, Ltd. (Usa)1984-10-22
SALICYLATE TEST (K843180)Sclavo, Inc.1984-09-07
DETERMIN. OF SALICYLATE IN SERUM/PLAST (K840243)Sigma Chemical Co.1984-03-23
PARAMAX SALICYLATE REAGENT (K833003)American Dade1983-10-28
SALICYLATE ASSAY KIT (K831336)Quantimetrix Corp.1983-07-07
TOXI-LAB RAPID SCREEN (K823523)Marion Laboratories, Inc.1983-01-14
SALICYLATES (K813431)Bio-Analytics Laboratories, Inc.1982-03-25
SALICYLATE STAT-PAK (K813185)Clin Tech Diagnostics Corp.1981-11-24

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