Panels › Clinical Chemistry › Product code JIF · Class 1
Enzymatic Method, Ammonia
Regulation 862.1065
0510(k)s in 12 months (30 all time)
0recalls in 12 months (11 all time)
11recalls that name a 510(k)
Top companies in JIF
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 8, 2019 | K183517 | Ammonia II Roche Diagnostics Operations (Rdo) | JIF |
| Mar 7, 2013 | K123677 | DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) Siemens Healthcare Diagnostics | JIF |
| Feb 15, 2013 | K123320 | DIMENSION AMMONIA FLEX REAGENT CARTRIDGE Siemens Healthcare Diagnostics | JIF |
| Sep 6, 2006 | K062316 | DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE Dade Behring, Inc. | JIF |
| Nov 25, 2005 | K051114 | SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY Sentinel Ch. Srl, IT | JIF |
| Mar 10, 2004 | K033921 | AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 Diagnostic Chemicals , Ltd., CA | JIF |
| May 12, 2003 | K030873 | RANDOX AMMONIA Randox Laboratories, Ltd., GB | JIF |
| Dec 24, 2002 | K023841 | AMMONIA ASSAY FOR THE ADVIA 1650 Bayer Diagnostics Corp. | JIF |
| Jul 13, 2002 | K021151 | AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM Bayer Diagnostics Corp. | JIF |
| Dec 22, 2000 | K003196 | SYNCHRON SYSTEMS AMMONIA REAGENT Beckman Coulter, Inc. | JIF |
| Jun 2, 2000 | K001285 | AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 Diagnostic Chemicals , Ltd., CA | JIF |
| Jan 29, 1999 | K984402 | SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT Beckman Coulter, Inc. | JIF |
| Jul 22, 1998 | K981920 | AMM Abbott Laboratories | JIF |
| Jun 22, 1998 | K981467 | AMM Abbott Laboratories | JIF |
| Jan 2, 1998 | K974620 | AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) Trace America, Inc. | JIF |
| Nov 22, 1996 | K964565 | PARAMAX AMMONIA AND AMMONIA BLANK REAGENT Dade Intl., Inc. | JIF |
| Aug 2, 1994 | K932556 | AMMONIA ASSAY CAT. NO. 200-02 Diagnostic Chemicals, Ltd. (Usa), CA | JIF |
| Apr 26, 1994 | K934925 | BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR Beckman Instruments, Inc. | JIF |
| Feb 26, 1992 | K915707 | AMMONIA REAGENT SET Tech Intl. Co. | JIF |
| Aug 12, 1991 | K913124 | ROCHE REAGENT FOR AMMONIA Roche Diagnostic Systems, Inc. | JIF |
| Mar 24, 1988 | K880651 | PARAMAX AMMONIA REAGENT Baxter Healthcare Corp | JIF |
| Jul 1, 1987 | K872110 | EASY-TEST AMMONIA (AMON) ITEM NO. 16695 Em Diagnostic Systems, Inc. | JIF |
| Mar 31, 1987 | K870787 | ABBOTT SPECTRUM AMMONIA REAGENT Abbott Laboratories | JIF |
| Feb 11, 1987 | K870143 | AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95 Em Diagnostic Systems, Inc. | JIF |
| Jan 5, 1987 | K864706 | RAICHEM(TM) AMMONIA REAGENT Reagents Applications, Inc. | JIF |
| Apr 4, 1984 | K840770 | PARAMAX AMMONIA REAGENTT American Dade | JIF |
| Jun 24, 1982 | K821719 | AMMONIA REAGENT Gilford Diagnostics | JIF |
| Apr 8, 1977 | K770363 | ACA AMMONIA ANALYTICAL TEST PACK E.I. Dupont DE Nemours & Co., Inc. | JIF |
| Mar 1, 1977 | K770273 | TEST, AMMONIA, BMC REAGENTSET Boehringer Mannheim Corp. | JIF |
| Aug 23, 1976 | K760332 | SIGMA AMMONIA REAGENT Sigma Chemical Co. | JIF |
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