510(k) K810727
K810727 is an FDA 510(k) premarket notification submitted by The Dow Chemical Co. for the device "AST-UV (PLP-ACTIVATED) DETERMINATION". The FDA issued a decision of Substantially Equivalent on March 31, 1981. The device falls under product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. The Dow Chemical Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 1981
- Date Received
- March 17, 1981
- 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