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JIF — Enzymatic Method, Ammonia Class I

FDA Device Classification

Classification Details

Product Code
JIF
Device Class
Class I
Regulation Number
862.1065
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K183517roche diagnostics operations (rdo)Ammonia IIFebruary 8, 2019
K123677siemens healthcare diagnosticsDIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CMarch 7, 2013
K123320siemens healthcare diagnosticsDIMENSION AMMONIA FLEX REAGENT CARTRIDGEFebruary 15, 2013
K062316dade behringDIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGESeptember 6, 2006
K051114sentinel chSENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAYNovember 25, 2005
K033921diagnostic chemicalsAMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10March 10, 2004
K030873randox laboratoriesRANDOX AMMONIAMay 12, 2003
K023841bayer diagnosticsAMMONIA ASSAY FOR THE ADVIA 1650December 24, 2002
K021151bayer diagnosticsAMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMJuly 13, 2002
K003196beckman coulterSYNCHRON SYSTEMS AMMONIA REAGENTDecember 22, 2000
K001285diagnostic chemicalsAMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30June 2, 2000
K984402beckman coulterSYNCHRON SYSTEMS AMMONIA (AMM) REAGENTJanuary 29, 1999
K981920abbott laboratoriesAMMJuly 22, 1998
K981467abbott laboratoriesAMMJune 22, 1998
K974620trace americaAMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)January 2, 1998
K964565dade intlPARAMAX AMMONIA AND AMMONIA BLANK REAGENTNovember 22, 1996
K932556diagnostic chemicals, ltd. (usa)AMMONIA ASSAY CAT. NO. 200-02August 2, 1994
K934925beckman instrumentsBECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATORApril 26, 1994
K915707tech intlAMMONIA REAGENT SETFebruary 26, 1992
K913124roche diagnostic systemsROCHE REAGENT FOR AMMONIAAugust 12, 1991