510(k) K792416
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 1979
- Date Received
- November 26, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- 2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase
- Device Class
- Class II
- Regulation Number
- 862.1440
- Review Panel
- CH
- Submission Type