510(k) K760598
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 1976
- Date Received
- September 7, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, For Isolation Of Pathogenic Neisseria
- Device Class
- Class II
- Regulation Number
- 866.2410
- Review Panel
- MI
- Submission Type