510(k) K121339
K121339 is an FDA 510(k) premarket notification submitted by Chemtron Biotech, Inc. for the device "CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS". The FDA issued a decision of Substantially Equivalent on May 17, 2012. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Chemtron Biotech, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 2012
- Date Received
- May 3, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Amphetamine
- Device Class
- Class II
- Regulation Number
- 862.3100
- Review Panel
- TX
- Submission Type