510(k) K964765
K964765 is an FDA 510(k) premarket notification submitted by Chiron Diagnostics Corp. for the device "CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY". The FDA issued a decision of Substantially Equivalent on February 14, 1997. The device falls under product code KLT (Enzyme Immunoassay, Carbamazepine), a Class II device regulated under 21 CFR 862.3645. Chiron Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 1997
- Date Received
- November 27, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Carbamazepine
- Device Class
- Class II
- Regulation Number
- 862.3645
- Review Panel
- TX
- Submission Type