510(k) K153192
K153192 is an FDA 510(k) premarket notification submitted by Chemtron Biotech, Inc. for the device "Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests". The FDA issued a decision of Substantially Equivalent on April 18, 2016. 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 18, 2016
- Date Received
- November 3, 2015
- 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