DEL
5 FDA 510(k) clearances · Product code
44 daysmedian time to decision
52 days90th percentile
5clearances measured
FDA profile
- Official device name
- Lipoprotein X, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5590
- Medical specialty
- Immunology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TINA-QUANT APOLIPOPROTEIN A-1 VER.2 (K013278) | Roche Diagnostics Corp. | 2001-11-15 |
| APOLIPOPROTEIN A-I (APO A-I) (K901675) | Sigma Chemical Co. | 1990-04-26 |
| APOLIPOPROTEIN B (APO B) (K900124) | Sigma Chemical Co. | 1990-03-02 |
| ORTHO *APO A-1 ELISA TEST SYSTEM (K895160) | Medical Marketing Consultants, Inc. | 1989-10-06 |
| BACTON TM, BASIC TM, APO A-I REAGENT (K893885) | Catachem, Inc. | 1989-06-21 |
Track DEL automatically
Every clearance here is in the API, with alerts when new ones post.