510(k) K001953
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 2000
- Date Received
- June 27, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Manual Antimicrobial Susceptibility Test Systems
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type