510(k) K130082
K130082 is an FDA 510(k) premarket notification submitted by Genprime, Inc. for the device "GENPRIME DRUGS OF ABUSE READER SYSTEM". The FDA issued a decision of Substantially Equivalent on December 20, 2013. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Genprime, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2013
- Date Received
- January 14, 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