510(k) K143599
K143599 is an FDA 510(k) premarket notification submitted by Chemtron Biotech, Inc. for the device "Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000". The FDA issued a decision of Substantially Equivalent on April 17, 2015. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Chemtron Biotech, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2015
- Date Received
- December 18, 2014
- 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