510(k) K112586
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2011
- Date Received
- September 6, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Susceptibility Test Discs, Antimicrobial
- Device Class
- Class II
- Regulation Number
- 866.1620
- Review Panel
- MI
- Submission Type