LHK
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antigen, Id, Candida Albicans
- 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 |
|---|---|---|
| DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST (K893753) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-16 |
| CANDIDA DETECTION SYSTEM (K823016) | Ramco Laboratories, Inc. | 1982-12-28 |
| REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS (K812741) | Nolan Biological Laboratories, Inc. | 1981-10-23 |
| CANDIDA IMMUNODIFFUSION SYSTEM (K812186) | American Scientific Products | 1981-08-25 |
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Every clearance here is in the API, with alerts when new ones post.