LRF
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Candida Spp., Direct Antigen, Id
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3165
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ON THE SPOT CANDIDASURE (K883118) | Medi-Tech, Inc. | 1988-09-30 |
| CANDIDATE(R) SUPER (K863499) | Mercia Diagnostics , Ltd. | 1987-03-19 |
| EI-CANDIDA ENZYME IMMUNOASSAY EI1001 (K843286) | Immuno-Mycologics, Inc. | 1984-10-01 |
Track LRF automatically
Every clearance here is in the API, with alerts when new ones post.