510(k) K941497
K941497 is an FDA 510(k) premarket notification submitted by Solarcare, Inc. for the device "SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY". The FDA issued a decision of Substantially Equivalent on May 24, 1994. The device falls under product code CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Solarcare, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 1994
- Date Received
- March 28, 1994
- 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