510(k) K130811
K130811 is an FDA 510(k) premarket notification submitted by Psychemedics Corp. for the device "PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE". The FDA issued a decision of Substantially Equivalent on May 2, 2013. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Psychemedics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2013
- Date Received
- March 25, 2013
- 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