510(k) K901105
K901105 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PARAMAX ALANINE AMINOTRANSFERASE REAGENT". The FDA issued a decision of Substantially Equivalent on Mar 23, 1990. The device falls under product code CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 23, 1990
- Date Received
- Mar 8, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Nadh Oxidation/Nad Reduction, Alt/Sgpt
- Device Class
- Class I
- Regulation Number
- 862.1030
- Review Panel
- CH
- Submission Type
- 510(k) Exempt