510(k) K823833
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 1983
- Date Received
- December 21, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, General Purpose, Microbiology, Diagnostic
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type