JXB
16 FDA 510(k) clearances · Product code
69 daysmedian time to decision
184 days90th percentile
16clearances measured
FDA profile
- Official device name
- Kit, Identification, Yeast
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 2016: 16 · 2017: 18 · 2018: 27 · 2019: 19 · 2020: 12 · 2021: 37
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| YEAST TRAFFIC LIGHT PNA FISH (K080719) | Advandx, Inc. | 2008-09-12 |
| C. ALBICANS PNA FISH (K062461) | Advandx, Inc. | 2006-10-25 |
| YEASTEST (K993554) | Diagnostic Markers, Inc. | 2000-02-10 |
| RAPID YEAST PLUS SYSTEM (K943621) | Innovative Diagnostic Systems, Inc. | 1995-01-27 |
| BACTICARD CANDIDA (K935124) | Remel Co. | 1994-02-25 |
| MICRORING YT (K900112) | Medical Wire & Equipment Co. | 1990-07-31 |
| VITEK YEAST BIOCHEMICAL CARD (K881925) | Vitek Systems, Inc. | 1988-06-16 |
| YEAST IDENTIFICATION PANEL (K860575) | American Micro Scan | 1986-05-13 |
| YEAST IDENT (K830286) | Analytical Products, Inc. | 1983-04-05 |
| MS-2 IDENTIFICATION SYSTEM (K802309) | Abbott Laboratories | 1980-12-01 |
| NITRATE SWAB-RAPID TEST (K800803) | Remel Co. | 1980-07-08 |
| CAPIK-CANDIDA ALBICANS IDENT. KIT. (K800908) | Immuno-Mycologics, Inc. | 1980-06-02 |
| AMS YEAST BIOCHEMICAL CARD (K792231) | Vitek Systems, Inc. | 1979-12-19 |
| YEAST-PALETTE TM (K790991) | Micro-Palettes, Inc. | 1979-06-22 |
| DERMATOPHYTIN O (K790671) | Diagnostica, Inc. | 1979-05-31 |
| API 20C (K771008) | Analytical Products, Inc. | 1977-08-03 |
Track JXB automatically
Every clearance here is in the API, with alerts when new ones post.