Enzymatic Method, Ammonia

FDA product code JIF · 30 cleared devices

Class 1 Clinical Chemistry

Regulation: 21 CFR 862.1065
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-23 – 2019-02-08

JIF 2019-02-08

Ammonia II

Applicant Roche Diagnostics Operations (Rdo)

K number K183517

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JIF 2013-03-07

DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)

Applicant Siemens Healthcare Diagnostics

K number K123677

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JIF 2013-02-15

DIMENSION AMMONIA FLEX REAGENT CARTRIDGE

Applicant Siemens Healthcare Diagnostics

K number K123320

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JIF 2006-09-06

DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE

Applicant Dade Behring, Inc.

K number K062316

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JIF 2005-11-25

SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY

Applicant Sentinel Ch. Srl

K number K051114

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JIF 2004-03-10

AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10

Applicant Diagnostic Chemicals , Ltd.

K number K033921

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JIF 2003-05-12

RANDOX AMMONIA

Applicant Randox Laboratories, Ltd.

K number K030873

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JIF 2002-12-24

AMMONIA ASSAY FOR THE ADVIA 1650

Applicant Bayer Diagnostics Corp.

K number K023841

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JIF 2002-07-13

AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

Applicant Bayer Diagnostics Corp.

K number K021151

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JIF 2000-12-22

SYNCHRON SYSTEMS AMMONIA REAGENT

Applicant Beckman Coulter, Inc.

K number K003196

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JIF 2000-06-02

AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30

Applicant Diagnostic Chemicals , Ltd.

K number K001285

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JIF 1999-01-29

SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT

Applicant Beckman Coulter, Inc.

K number K984402

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JIF 1998-07-22

AMM

Applicant Abbott Laboratories

K number K981920

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JIF 1998-06-22

AMM

Applicant Abbott Laboratories

K number K981467

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JIF 1998-01-02

AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)

Applicant Trace America, Inc.

K number K974620

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JIF 1996-11-22

PARAMAX AMMONIA AND AMMONIA BLANK REAGENT

Applicant Dade Intl., Inc.

K number K964565

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JIF 1994-08-02

AMMONIA ASSAY CAT. NO. 200-02

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K932556

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JIF 1994-04-26

BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR

Applicant Beckman Instruments, Inc.

K number K934925

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JIF 1992-02-26

AMMONIA REAGENT SET

Applicant Tech Intl. Co.

K number K915707

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JIF 1991-08-12

ROCHE REAGENT FOR AMMONIA

Applicant Roche Diagnostic Systems, Inc.

K number K913124

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JIF 1988-03-24

PARAMAX AMMONIA REAGENT

Applicant Baxter Healthcare Corp

K number K880651

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JIF 1987-07-01

EASY-TEST AMMONIA (AMON) ITEM NO. 16695

Applicant Em Diagnostic Systems, Inc.

K number K872110

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JIF 1987-03-31

ABBOTT SPECTRUM AMMONIA REAGENT

Applicant Abbott Laboratories

K number K870787

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JIF 1987-02-11

AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95

Applicant Em Diagnostic Systems, Inc.

K number K870143

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JIF 1987-01-05

RAICHEM(TM) AMMONIA REAGENT

Applicant Reagents Applications, Inc.

K number K864706

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JIF 1984-04-04

PARAMAX AMMONIA REAGENTT

Applicant American Dade

K number K840770

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JIF 1982-06-24

AMMONIA REAGENT

Applicant Gilford Diagnostics

K number K821719

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JIF 1977-04-08

ACA AMMONIA ANALYTICAL TEST PACK

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

K number K770363

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JIF 1977-03-01

TEST, AMMONIA, BMC REAGENTSET

Applicant Boehringer Mannheim Corp.

K number K770273

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JIF 1976-08-23

SIGMA AMMONIA REAGENT

Applicant Sigma Chemical Co.

K number K760332

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