Kit, Screening, Yeast
Kit, Screening, Yeast is a diagnostic microbiology kit used to screen clinical specimens or cultures for the presence of yeast organisms, providing a rapid preliminary detection result before confirmatory identification testing. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JXC, regulated under 21 CFR 866.2660, and falls within the Microbiology medical specialty.
Basic Information
- Product Code
- JXC
- Device Class
- FDA class 1
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K960075 | CHROMAGAR CANDIDA | Aug 02, 1996 | Substantially Equivalent | Hardy Diagnostics |
| K913426 | ALBICANS SURE | Apr 22, 1992 | Substantially Equivalent | Jrga Diagnostics |
| K884720 | GERM TUBE SOLUTION | Jun 02, 1989 | Substantially Equivalent | Remel Co. |
| K891476 | C. ALBICANS SCREEN | Apr 12, 1989 | Substantially Equivalent | Carr-Scarborough Microbiologicals, Inc. |
| K882371 | SOC SLIDE CULTURE SYSTEM | Jul 18, 1988 | Substantially Equivalent | The Cancer Center AT Wadley Institutes |
| K832406 | QUANTUM II YEAST IDENT. SYSTEM | Sep 26, 1983 | Substantially Equivalent | Abbott Laboratories |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.