510(k) K760401
K760401 is an FDA 510(k) premarket notification submitted by J.T. Baker Chemical Co. for the device "COCAINE KIT, TOXI-PAK". The FDA issued a decision of Substantially Equivalent on Aug 26, 1976. The device falls under product code DLN (Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)), a Class II device regulated under 21 CFR 862.3250. J.T. Baker Chemical Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 26, 1976
- Date Received
- Aug 6, 1976
- 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