510(k) K884724
K884724 is an FDA 510(k) premarket notification submitted by Catachem, Inc. for the device "ASPARTATE AMINOTRANSFERASE (AST)". The FDA issued a decision of Substantially Equivalent on March 8, 1989. The device falls under product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. Catachem, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 1989
- Date Received
- November 10, 1988
- 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