510(k) K822954
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 1982
- Date Received
- October 4, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Quality Control For Culture Media
- Device Class
- Class I
- Regulation Number
- 866.2480
- Review Panel
- MI
- Submission Type