JXC
6 FDA 510(k) clearances · Product code
204 daysmedian time to decision
265 days90th percentile
6clearances measured
FDA profile
- Official device name
- Kit, Screening, Yeast
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CHROMAGAR CANDIDA (K960075) | Hardy Diagnostics | 1996-08-02 |
| ALBICANS SURE (K913426) | Jrga Diagnostics | 1992-04-22 |
| GERM TUBE SOLUTION (K884720) | Remel Co. | 1989-06-02 |
| C. ALBICANS SCREEN (K891476) | Carr-Scarborough Microbiologicals, Inc. | 1989-04-12 |
| SOC SLIDE CULTURE SYSTEM (K882371) | The Cancer Center AT Wadley Institutes | 1988-07-18 |
| QUANTUM II YEAST IDENT. SYSTEM (K832406) | Abbott Laboratories | 1983-09-26 |
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Every clearance here is in the API, with alerts when new ones post.