510(k) K792429
K792429 is an FDA 510(k) premarket notification submitted by Tecknam, Inc. for the device "HIM TEST COCAINE". The FDA issued a decision of Substantially Equivalent on Dec 7, 1979. The device falls under product code DLN (Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)), a Class II device regulated under 21 CFR 862.3250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 7, 1979
- Date Received
- Nov 28, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)
- Device Class
- Class II
- Regulation Number
- 862.3250
- Review Panel
- TX
- Submission Type