JIF · Class I · 21 CFR 862.1065

FDA Product Code JIF: Enzymatic Method, Ammonia

Leading manufacturers include Abbott Laboratories, Diagnostic Chemicals , Ltd. and Beckman Coulter, Inc..

30
Total
30
Cleared
71d
Avg days
1976
Since

FDA 510(k) Cleared Enzymatic Method, Ammonia Devices (Product Code JIF)

30 devices
1–24 of 30
Cleared Feb 08, 2019
Ammonia II
K183517
Roche Diagnostics Operations (Rdo)
Chemistry · 52d
Cleared Mar 07, 2013
DIMENSION VISTA
K123677
Siemens Healthcare Diagnostics
Chemistry · 97d
Cleared Feb 15, 2013
DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
K123320
Siemens Healthcare Diagnostics
Chemistry · 112d
Cleared Sep 06, 2006
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
K062316
Dade Behring, Inc.
Chemistry · 28d
Cleared Nov 25, 2005
SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY
K051114
Sentinel Ch. Srl
Chemistry · 207d
Cleared Mar 10, 2004
AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
K033921
Diagnostic Chemicals , Ltd.
Chemistry · 83d
Cleared May 12, 2003
RANDOX AMMONIA
K030873
Randox Laboratories, Ltd.
Chemistry · 53d
Cleared Dec 24, 2002
AMMONIA ASSAY FOR THE ADVIA 1650
K023841
Bayer Diagnostics Corp.
Immunology · 36d
Cleared Jul 13, 2002
AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K021151
Bayer Diagnostics Corp.
Chemistry · 94d
Cleared Dec 22, 2000
SYNCHRON SYSTEMS AMMONIA REAGENT
K003196
Beckman Coulter, Inc.
Chemistry · 71d
Cleared Jun 02, 2000
AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30
K001285
Diagnostic Chemicals , Ltd.
Chemistry · 42d
Cleared Jan 29, 1999
SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT
K984402
Beckman Coulter, Inc.
Chemistry · 51d
Cleared Jul 22, 1998
AMM
K981920
Abbott Laboratories
Chemistry · 51d
Cleared Jun 22, 1998
AMM
K981467
Abbott Laboratories
Chemistry · 60d
Cleared Jan 02, 1998
AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
K974620
Trace America, Inc.
Chemistry · 22d
Cleared Nov 22, 1996
PARAMAX AMMONIA AND AMMONIA BLANK REAGENT
K964565
Dade Intl., Inc.
Chemistry · 8d
Cleared Aug 02, 1994
AMMONIA ASSAY CAT. NO. 200-02
K932556
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 433d
Cleared Apr 26, 1994
BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR
K934925
Beckman Instruments, Inc.
Chemistry · 193d
Cleared Aug 12, 1991
ROCHE REAGENT FOR AMMONIA
K913124
Roche Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Mar 24, 1988
PARAMAX AMMONIA REAGENT
K880651
Baxter Healthcare Corp
Chemistry · 36d
Cleared Jul 01, 1987
EASY-TEST AMMONIA (AMON) ITEM NO. 16695
K872110
Em Diagnostic Systems, Inc.
Chemistry · 30d
Cleared Mar 31, 1987
ABBOTT SPECTRUM AMMONIA REAGENT
K870787
Abbott Laboratories
Chemistry · 33d
Cleared Feb 11, 1987
AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95
K870143
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Jan 05, 1987
RAICHEM(TM) AMMONIA REAGENT
K864706
Reagents Applications, Inc.
Chemistry · 34d

About Product Code JIF - Regulatory Context