510(k) K130213
K130213 is an FDA 510(k) premarket notification submitted by Lumiquick Diagnostics, Inc. for the device "QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE". The FDA issued a decision of Substantially Equivalent on October 18, 2013. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2013
- Date Received
- January 29, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Cannabinoids
- Device Class
- Class II
- Regulation Number
- 862.3870
- Review Panel
- TX
- Submission Type