510(k) K020920
K020920 is an FDA 510(k) premarket notification submitted by Cozart Bioscience , Ltd. for the device "COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE". The FDA issued a decision of Substantially Equivalent on November 5, 2002. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Cozart Bioscience , Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 2002
- Date Received
- March 21, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Opiates
- Device Class
- Class II
- Regulation Number
- 862.3650
- Review Panel
- TX
- Submission Type