KTS
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Second Antibody (Species Specific Anti-Animal Gamma Globulin)
- 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 |
|---|---|---|
| SAC-CEL (K813508) | Burroughs Wellcome Co. | 1981-12-29 |
| CENTRIA RADIOIMMUNOASSAY SEPARATION (K792636) | Union Carbide Corp. | 1980-01-11 |
| CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT) (K792637) | Union Carbide Corp. | 1980-01-11 |
| SECOND ANTIBODY (K781070) | Pcl-Ria, Inc. | 1978-08-10 |
Track KTS automatically
Every clearance here is in the API, with alerts when new ones post.