510(k) K962744
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 1996
- Date Received
- July 15, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- Device Class
- Class II
- Regulation Number
- 866.1700
- Review Panel
- MI
- Submission Type