Panels › Clinical Chemistry › Product code JIQ · Class 1
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
Regulation 862.1645
0510(k)s in 12 months (13 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in JIQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Instruments, Inc. | 2 | 0 |
| Wako Chemicals USA, Inc. | 2 | 0 |
| Ausam Biotecthnologies, Inc. | 1 | 0 |
| Diagnostic Specialties | 1 | 0 |
| Dupont Medical Products | 1 | 0 |
| E K Ind., Inc. | 1 | 0 |
| HemoCue AB | 0 | 1 |
| Osborn Group, Inc. | 1 | 0 |
| Reagents Applications, Inc. | 1 | 0 |
| Roche Diagnostics Operations (Rdo) | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 9, 2014 | K141925 | TOTAL PROTEIN URINE/CSF GEN.3 Roche Diagnostics Operations (Rdo) | JIQ |
| Aug 14, 2003 | K013643 | AUSAM TOTAL ALBUMIN ASSAY Ausam Biotecthnologies, Inc. | JIQ |
| Sep 24, 1999 | K991800 | HEMOCHEK URINE COLLECTION KIT Osborn Group, Inc. | JIQ |
| Sep 2, 1997 | K971458 | ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT Diagnostic Specialties | JIQ |
| Apr 17, 1997 | K965035 | IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT Beckman Instruments, Inc. | JIQ |
| Feb 7, 1995 | K944664 | WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR Wako Chemicals USA, Inc. | JIQ |
| May 9, 1994 | K936202 | URINARY ALBUMIN TEST PACK Dupont Medical Products | JIQ |
| Apr 26, 1994 | K935662 | SYNERMED IR 500 CHEMISTRY ANALYZER Synermed, Inc., CA | JIQ |
| Sep 14, 1990 | K903123 | RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT Reagents Applications, Inc. | JIQ |
| Jun 18, 1990 | K902216 | WAKO(TM) MICRO-ALBUMIN Wako Chemicals USA, Inc. | JIQ |
| Dec 27, 1989 | K895883 | BECKMAN MA MICROALBUMIN REAGENT KIT Beckman Instruments, Inc. | JIQ |
| Oct 20, 1987 | K870516 | ALBUMIN SCREEN TEST Sclavo, Inc. | JIQ |
| Aug 10, 1984 | K842915 | SULFOSALICYLIC ACID, 3% W/V E K Ind., Inc. | JIQ |
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