510(k) K932049
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 1993
- Date Received
- April 27, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nadh Oxidation/Nad Reduction, Ast/Sgot
- Device Class
- Class II
- Regulation Number
- 862.1100
- Review Panel
- CH
- Submission Type