JXB — Kit, Identification, Yeast Class I
FDA Device Classification
Classification Details
- Product Code
- JXB
- Device Class
- Class I
- Regulation Number
- 866.2660
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K080719 | advandx | YEAST TRAFFIC LIGHT PNA FISH | September 12, 2008 |
| K062461 | advandx | C. ALBICANS PNA FISH | October 25, 2006 |
| K993554 | diagnostic markers | YEASTEST | February 10, 2000 |
| K943621 | innovative diagnostic systems | RAPID YEAST PLUS SYSTEM | January 27, 1995 |
| K935124 | remel | BACTICARD CANDIDA | February 25, 1994 |
| K900112 | medical wire and equipment | MICRORING YT | July 31, 1990 |
| K881925 | vitek systems | VITEK YEAST BIOCHEMICAL CARD | June 16, 1988 |
| K860575 | american micro scan | YEAST IDENTIFICATION PANEL | May 13, 1986 |
| K830286 | analytical products | YEAST IDENT | April 5, 1983 |
| K802309 | abbott laboratories | MS-2 IDENTIFICATION SYSTEM | December 1, 1980 |
| K800803 | remel | NITRATE SWAB-RAPID TEST | July 8, 1980 |
| K800908 | immuno-mycologics | CAPIK-CANDIDA ALBICANS IDENT. KIT. | June 2, 1980 |
| K792231 | vitek systems | AMS YEAST BIOCHEMICAL CARD | December 19, 1979 |
| K790991 | micro-palettes | YEAST-PALETTE TM | June 22, 1979 |
| K790671 | diagnostica | DERMATOPHYTIN O | May 31, 1979 |
| K771008 | analytical products | API 20C | August 3, 1977 |