510(k) K940682
K940682 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "AXSYM(TM) QUINIDINE". The FDA issued a decision of Substantially Equivalent on June 21, 1994. The device falls under product code LGI (Fluorescence Polarization Immunoassay, Carbamazepine), a Class II device regulated under 21 CFR 862.3645. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 1994
- Date Received
- February 10, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluorescence Polarization Immunoassay, Carbamazepine
- Device Class
- Class II
- Regulation Number
- 862.3645
- Review Panel
- TX
- Submission Type