JXC — Kit, Screening, Yeast Class I
FDA product code JXC covers "Kit, Screening, Yeast", a Class I medical device regulated under 21 CFR 866.2660. Submissions are reviewed by the Microbiology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JXC
- 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 |
|---|---|---|---|
| K960075 | hardy diagnostics | CHROMAGAR CANDIDA | August 2, 1996 |
| K913426 | jrga diagnostics | ALBICANS SURE | April 22, 1992 |
| K884720 | remel | GERM TUBE SOLUTION | June 2, 1989 |
| K891476 | carr-scarborough microbiologicals | C. ALBICANS SCREEN | April 12, 1989 |
| K882371 | cancer center at wadley institutes | SOC SLIDE CULTURE SYSTEM | July 18, 1988 |
| K832406 | abbott laboratories | QUANTUM II YEAST IDENT. SYSTEM | September 26, 1983 |