JSY — Kit, Identification, Mycobacteria Class I
FDA Device Classification
Classification Details
- Product Code
- JSY
- 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 |
|---|
| K943050 | dynagen | MYCOAKT M KANSASII CULTURE ID KIT | March 13, 1995 |
| K943051 | dynagen | MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT | March 13, 1995 |
| K943049 | dynagen | MYCOAKT M. AVIUM CULTURE ID KIT | March 13, 1995 |
| K880990 | alpha-tec systems | ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION | March 24, 1988 |
| K830211 | analytical products | API TB-IDENT* | March 24, 1983 |