Atlas FDA

JIF

30 FDA 510(k) clearances · Product code

51 daysmedian time to decision
193 days90th percentile
30clearances measured

FDA profile

Official device name
Enzymatic Method, Ammonia
Device class
Class I (low risk)
Regulation
21 CFR 862.1065
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
1997: 2 · 2000: 3 · 2011: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Ammonia II (K183517)Roche Diagnostics Operations (Rdo)2019-02-08
DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) (K123677)Siemens Healthcare Diagnostics2013-03-07
DIMENSION AMMONIA FLEX REAGENT CARTRIDGE (K123320)Siemens Healthcare Diagnostics2013-02-15
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE (K062316)Dade Behring, Inc.2006-09-06
SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY (K051114)Sentinel Ch. Srl2005-11-25
AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 (K033921)Diagnostic Chemicals , Ltd.2004-03-10
RANDOX AMMONIA (K030873)Randox Laboratories, Ltd.2003-05-12
AMMONIA ASSAY FOR THE ADVIA 1650 (K023841)Bayer Diagnostics Corp.2002-12-24
AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K021151)Bayer Diagnostics Corp.2002-07-13
SYNCHRON SYSTEMS AMMONIA REAGENT (K003196)Beckman Coulter, Inc.2000-12-22
AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 (K001285)Diagnostic Chemicals , Ltd.2000-06-02
SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT (K984402)Beckman Coulter, Inc.1999-01-29
AMM (K981920)Abbott Laboratories1998-07-22
AMM (K981467)Abbott Laboratories1998-06-22
AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) (K974620)Trace America, Inc.1998-01-02
PARAMAX AMMONIA AND AMMONIA BLANK REAGENT (K964565)Dade Intl., Inc.1996-11-22
AMMONIA ASSAY CAT. NO. 200-02 (K932556)Diagnostic Chemicals, Ltd. (Usa)1994-08-02
BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR (K934925)Beckman Instruments, Inc.1994-04-26
AMMONIA REAGENT SET (K915707)Tech Intl. Co.1992-02-26
ROCHE REAGENT FOR AMMONIA (K913124)Roche Diagnostic Systems, Inc.1991-08-12
PARAMAX AMMONIA REAGENT (K880651)Baxter Healthcare Corp1988-03-24
EASY-TEST AMMONIA (AMON) ITEM NO. 16695 (K872110)Em Diagnostic Systems, Inc.1987-07-01
ABBOTT SPECTRUM AMMONIA REAGENT (K870787)Abbott Laboratories1987-03-31
AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95 (K870143)Em Diagnostic Systems, Inc.1987-02-11
RAICHEM(TM) AMMONIA REAGENT (K864706)Reagents Applications, Inc.1987-01-05
PARAMAX AMMONIA REAGENTT (K840770)American Dade1984-04-04
AMMONIA REAGENT (K821719)Gilford Diagnostics1982-06-24
ACA AMMONIA ANALYTICAL TEST PACK (K770363)E.I. Dupont DE Nemours & Co., Inc.1977-04-08
TEST, AMMONIA, BMC REAGENTSET (K770273)Boehringer Mannheim Corp.1977-03-01
SIGMA AMMONIA REAGENT (K760332)Sigma Chemical Co.1976-08-23

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