FDA Product Code
FDA Product Code JZJ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5060
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K000661 | RANDOX PREALBUMIN | Randox Laboratories, Ltd. | 2000-04-13 | Traditional | PDF ↗ |
| K972638 | TINA-QUANT PREALBUMIN | Boehringer Mannheim Corp. | 1998-01-09 | Traditional | PDF ↗ |
| K951966 | HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT | Kent Laboratories, Inc. | 1995-06-01 | Traditional | PDF ↗ |
| K913672 | PREALBUMIN IMMUNOLOGICAL NL TEST KIT | The Binding Site, Ltd. | 1991-12-20 | Traditional | PDF ↗ |
| K884298 | SPQ(TM) TEST SYSTEM FOR MICROALBUMIN | Atlantic Antibodies | 1988-11-02 | Traditional | PDF ↗ |
| K884297 | SPQ(TM) TEST SYSTEM FOR PREALBUMIN | Atlantic Antibodies | 1988-11-02 | Traditional | PDF ↗ |
| K883002 | QM300 PREALBUMIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-09-22 | Traditional | PDF ↗ |
| K850686 | ANTISERUM TO HUMAN PREALBUMIN | Kent Laboratories, Inc. | 1985-11-01 | Traditional | PDF ↗ |
| K851912 | LASER PREALBUMIN TEST | Behring Diagnostics, Inc. | 1985-06-21 | Traditional | PDF ↗ |
| K821135 | PREALBUMIN ENZYME IMMUNOASSAY | Abbott Laboratories | 1983-05-05 | Traditional | PDF ↗ |
| K772329 | LAS-R HUMAN PREALBUMIN TEST | Hyland Therapeutic Div., Travenol Laboratories | 1978-02-03 | Traditional | PDF ↗ |
Product code JZJ · Class I · Immunology. Data: openFDA.