510(k) K024339
K024339 is an FDA 510(k) premarket notification submitted by Cozart Bioscience , Ltd. for the device "COZART EIA OPIATES ORAL FLUID KIT". The FDA issued a decision of Substantially Equivalent on April 7, 2003. The device falls under product code DIG (Cholinesterase Test Paper), a Class I device regulated under 21 CFR 862.3240. Cozart Bioscience , Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 2003
- Date Received
- December 27, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cholinesterase Test Paper
- Device Class
- Class I
- Regulation Number
- 862.3240
- Review Panel
- TX
- Submission Type