510(k) K771008
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 1977
- Date Received
- June 3, 1977
- 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