510(k) K900112
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 1990
- Date Received
- January 9, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Identification, Yeast
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type