510(k) K780733
K780733 is an FDA 510(k) premarket notification submitted by Vitek Systems, Inc. for the device "ANTICONVULSANTS III CALIBRATOR KIT". The FDA issued a decision of Substantially Equivalent on June 22, 1978. The device falls under product code DKH (Gas Chromatography, Diphenylhydantoin), a Class II device regulated under 21 CFR 862.3350. Vitek Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 1978
- Date Received
- May 2, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gas Chromatography, Diphenylhydantoin
- Device Class
- Class II
- Regulation Number
- 862.3350
- Review Panel
- TX
- Submission Type