JZJ
11 FDA 510(k) clearances · Product code
51 daysmedian time to decision
253 days90th percentile
11clearances measured
FDA profile
- Official device name
- Prealbumin, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5060
- Medical specialty
- Immunology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RANDOX PREALBUMIN (K000661) | Randox Laboratories, Ltd. | 2000-04-13 |
| TINA-QUANT PREALBUMIN (K972638) | Boehringer Mannheim Corp. | 1998-01-09 |
| HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT (K951966) | Kent Laboratories, Inc. | 1995-06-01 |
| PREALBUMIN IMMUNOLOGICAL NL TEST KIT (K913672) | The Binding Site, Ltd. | 1991-12-20 |
| SPQ(TM) TEST SYSTEM FOR MICROALBUMIN (K884298) | Atlantic Antibodies | 1988-11-02 |
| SPQ(TM) TEST SYSTEM FOR PREALBUMIN (K884297) | Atlantic Antibodies | 1988-11-02 |
| QM300 PREALBUMIN ANTIBODY PACK (K883002) | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-09-22 |
| ANTISERUM TO HUMAN PREALBUMIN (K850686) | Kent Laboratories, Inc. | 1985-11-01 |
| LASER PREALBUMIN TEST (K851912) | Behring Diagnostics, Inc. | 1985-06-21 |
| PREALBUMIN ENZYME IMMUNOASSAY (K821135) | Abbott Laboratories | 1983-05-05 |
| LAS-R HUMAN PREALBUMIN TEST (K772329) | Hyland Therapeutic Div., Travenol Laboratories | 1978-02-03 |
Track JZJ automatically
Every clearance here is in the API, with alerts when new ones post.