LGP
5 FDA 510(k) clearances · Product code
82 daysmedian time to decision
97 days90th percentile
5clearances measured
FDA profile
- Official device name
- Assay, Alpha-2-Antiplasmin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY (K864213) | Instrumentation Laboratory CO | 1986-11-25 |
| GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY (K850411) | Warner-Lambert Co. | 1985-05-08 |
| COATEST ANTIPLASMIN (K833890) | Kabivitrum, Inc. | 1984-01-30 |
| ALPHA-ANTIPLASM ASSAY (K802840) | American Dade | 1981-02-17 |
| PROTEOLYTIC ENZYME CONTROL (K803110) | American Dade | 1981-02-17 |
Track LGP automatically
Every clearance here is in the API, with alerts when new ones post.