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JIR — Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Class I

FDA Device Classification

Classification Details

Product Code
JIR
Device Class
Class I
Regulation Number
862.1645
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K222921healthy.ioMinuteful-kidney testSeptember 8, 2023
K210069healthy.ioMinuteful - kidney testJuly 6, 2022
K150330acon laboratoriesMission Urinalysis Reagent Strips (Microalbumin/Creatinine)April 30, 2015
K061419teco diagnosticsTECO MICROALBUMIN 2-1 COMBO STRIPSJanuary 26, 2007
K022538diagnostic chemicals, ltd. (usa)IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25August 23, 2002
K001810flexsite diagnosticsURISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTINGAugust 14, 2000
K994035diagnostic chemicalsIMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15February 1, 2000
K992257bayerNEW MULTIPLES REAGENT STRIPSNovember 24, 1999
K991315bayerMICROALBUSTIX REAGENT STRIPS (OTC)November 12, 1999
K983774abbott laboratoriesUALBJanuary 28, 1999
K972960tcpiHEALTH CHECK URI-TEST PROTEIN IN URINEOctober 7, 1998
K982219bayerMICROALBUSTIX REAGENT STRIPSAugust 12, 1998
K972337diagnostic chemicalsDCLARE IMMUNODIP STICKFOR MICROALBUMINURIAAugust 8, 1997
K970932american laboratory products coORGENTEC MICRO-ALBUMIN EIA ASSAYApril 8, 1997
K963142bayerDCA 2000 + MICROALBUMIN/CREATININE ASSAYSeptember 27, 1996
K951222randox laboratoriesTOTAL PROTEIN (URINE)April 24, 1996
K960274orgentecORGENTEC MICRO-ALBUMIN PIN EIA ASSAYMarch 29, 1996
K955438teco diagnosticsURINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)January 29, 1996
K954346boehringer mannheimCHEMSTRIP MICRAL URINE TEST STRIPSOctober 26, 1995
K932950boehringer mannheimTINA-QUANT MICROALBUMINFebruary 10, 1995