510(k) K030234
K030234 is an FDA 510(k) premarket notification submitted by Cozart Bioscience , Ltd. for the device "COZART EIA COCAINE ORAL FLIUD KIT". The FDA issued a decision of Substantially Equivalent on April 28, 2003. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Cozart Bioscience , Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2003
- Date Received
- January 23, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Cocaine And Cocaine Metabolites
- Device Class
- Class II
- Regulation Number
- 862.3250
- Review Panel
- TX
- Submission Type