LRF — Candida Spp., Direct Antigen, Id Class II
FDA Device Classification
Classification Details
- Product Code
- LRF
- Device Class
- Class II
- Regulation Number
- 866.3165
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K883118 | medi-tech | ON THE SPOT CANDIDASURE | September 30, 1988 |
| K863499 | mercia diagnostics | CANDIDATE(R) SUPER | March 19, 1987 |
| K843286 | immuno-mycologics | EI-CANDIDA ENZYME IMMUNOASSAY EI1001 | October 1, 1984 |