FDA Product Code
FDA Product Code DEL — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5590
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K013278 | TINA-QUANT APOLIPOPROTEIN A-1 VER.2 | Roche Diagnostics Corp. | 2001-11-15 | Traditional | PDF ↗ |
| K901675 | APOLIPOPROTEIN A-I (APO A-I) | Sigma Chemical Co. | 1990-04-26 | Traditional | PDF ↗ |
| K900124 | APOLIPOPROTEIN B (APO B) | Sigma Chemical Co. | 1990-03-02 | Traditional | PDF ↗ |
| K895160 | ORTHO *APO A-1 ELISA TEST SYSTEM | Medical Marketing Consultants, Inc. | 1989-10-06 | Traditional | PDF ↗ |
| K893885 | BACTON TM, BASIC TM, APO A-I REAGENT | Catachem, Inc. | 1989-06-21 | Traditional | PDF ↗ |
Product code DEL · Class I · Immunology. Data: openFDA.