DAA
5 FDA 510(k) clearances · Product code
34 daysmedian time to decision
150 days90th percentile
5clearances measured
FDA profile
- Official device name
- Igg, Peroxidase, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ANA MICROZYME TEST SYS #1610 (K832675) | Clinical Sciences, Inc. | 1983-09-12 |
| ANTINUCLEAR ANTIBODY TEST KIT (K831927) | Breit Laboratories, Inc. | 1983-07-18 |
| IP SPECIFIC G (K830005) | Diagnostic Reagent Tech. | 1983-06-02 |
| ANAZYME ANA PEROXIDASE TEST SYSTEM (K822911) | Clinical Sciences, Inc. | 1982-10-22 |
| INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL (K791749) | Clinical Sciences, Inc. | 1979-10-17 |
Track DAA automatically
Every clearance here is in the API, with alerts when new ones post.