510(k) K851518
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 1985
- Date Received
- April 15, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
- Device Class
- Class II
- Regulation Number
- 866.1700
- Review Panel
- MI
- Submission Type