JIQ · Class I · 21 CFR 862.1645

FDA Product Code JIQ: Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)

Leading manufacturers include Beckman Instruments, Inc., Wako Chemicals USA, Inc. and Diagnostic Specialties.

13
Total
13
Cleared
157d
Avg days
1984
Since

FDA 510(k) Cleared Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) Devices (Product Code JIQ)

13 devices
1–13 of 13
Cleared Dec 09, 2014
TOTAL PROTEIN URINE/CSF GEN.3
K141925
Roche Diagnostics Operations (Rdo)
Chemistry · 146d
Cleared Sep 24, 1999
HEMOCHEK URINE COLLECTION KIT
K991800
Osborn Group, Inc.
Chemistry · 121d
Cleared Sep 02, 1997
ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT
K971458
Diagnostic Specialties
Chemistry · 133d
Cleared Apr 17, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT
K965035
Beckman Instruments, Inc.
Immunology · 121d
Cleared Feb 07, 1995
WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR
K944664
Wako Chemicals USA, Inc.
Chemistry · 138d
Cleared May 09, 1994
URINARY ALBUMIN TEST PACK
K936202
Dupont Medical Products
Chemistry · 131d
Cleared Apr 26, 1994
SYNERMED IR 500 CHEMISTRY ANALYZER
K935662
Synermed, Inc.
Chemistry · 151d
Cleared Sep 14, 1990
RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT
K903123
Reagents Applications, Inc.
Chemistry · 60d
Cleared Jun 18, 1990
WAKO(TM) MICRO-ALBUMIN
K902216
Wako Chemicals USA, Inc.
Chemistry · 33d
Cleared Dec 27, 1989
BECKMAN MA MICROALBUMIN REAGENT KIT
K895883
Beckman Instruments, Inc.
Chemistry · 83d
Cleared Oct 20, 1987
ALBUMIN SCREEN TEST
K870516
Sclavo, Inc.
Chemistry · 258d
Cleared Aug 10, 1984
SULFOSALICYLIC ACID, 3% W/V
K842915
E K Ind., Inc.
Chemistry · 16d

About Product Code JIQ - Regulatory Context