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JIQ — Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) Class I

FDA Device Classification

Classification Details

Product Code
JIQ
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
K141925roche diagnostics operations (rdo)TOTAL PROTEIN URINE/CSF GEN.3December 9, 2014
K013643ausam biotecthnologiesAUSAM TOTAL ALBUMIN ASSAYAugust 14, 2003
K991800osborn groupHEMOCHEK URINE COLLECTION KITSeptember 24, 1999
K971458diagnostic specialtiesENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KITSeptember 2, 1997
K965035beckman instrumentsIMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENTApril 17, 1997
K944664wako chemicals usaWAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATORFebruary 7, 1995
K936202dupont medical productsURINARY ALBUMIN TEST PACKMay 9, 1994
K935662synermedSYNERMED IR 500 CHEMISTRY ANALYZERApril 26, 1994
K903123reagents applicationsRAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENTSeptember 14, 1990
K902216wako chemicals usaWAKO(TM) MICRO-ALBUMINJune 18, 1990
K895883beckman instrumentsBECKMAN MA MICROALBUMIN REAGENT KITDecember 27, 1989
K870516sclavoALBUMIN SCREEN TESTOctober 20, 1987
K842915e k indSULFOSALICYLIC ACID, 3% W/VAugust 10, 1984