FDA Product Code
FDA Product Code JIQ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1645
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K141925 | TOTAL PROTEIN URINE/CSF GEN.3 | Roche Diagnostics Operations (Rdo) | 2014-12-09 | Special | PDF ↗ |
| K013643 | AUSAM TOTAL ALBUMIN ASSAY | Ausam Biotecthnologies, Inc. | 2003-08-14 | Traditional | PDF ↗ |
| K991800 | HEMOCHEK URINE COLLECTION KIT | Osborn Group, Inc. | 1999-09-24 | Traditional | PDF ↗ |
| K971458 | ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT | Diagnostic Specialties | 1997-09-02 | Traditional | PDF ↗ |
| K965035 | IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT | Beckman Instruments, Inc. | 1997-04-17 | Traditional | PDF ↗ |
| K944664 | WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR | Wako Chemicals USA, Inc. | 1995-02-07 | Traditional | PDF ↗ |
| K936202 | URINARY ALBUMIN TEST PACK | Dupont Medical Products | 1994-05-09 | Traditional | PDF ↗ |
| K935662 | SYNERMED IR 500 CHEMISTRY ANALYZER | Synermed, Inc. | 1994-04-26 | Traditional | PDF ↗ |
| K903123 | RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT | Reagents Applications, Inc. | 1990-09-14 | Traditional | PDF ↗ |
| K902216 | WAKO(TM) MICRO-ALBUMIN | Wako Chemicals USA, Inc. | 1990-06-18 | Traditional | PDF ↗ |
| K895883 | BECKMAN MA MICROALBUMIN REAGENT KIT | Beckman Instruments, Inc. | 1989-12-27 | Traditional | PDF ↗ |
| K870516 | ALBUMIN SCREEN TEST | Sclavo, Inc. | 1987-10-20 | Traditional | PDF ↗ |
| K842915 | SULFOSALICYLIC ACID, 3% W/V | E K Ind., Inc. | 1984-08-10 | Traditional | PDF ↗ |
Product code JIQ · Class I · Clinical Chemistry. Data: openFDA.