510(k) K946283
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 1995
- Date Received
- December 27, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Non-Propagating Transport
- Device Class
- Class I
- Regulation Number
- 866.2390
- Review Panel
- MI
- Submission Type