510(k) K014066
K014066 is an FDA 510(k) premarket notification submitted by Princeton BioMeditech Corp. for the device "LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC". The FDA issued a decision of Substantially Equivalent on June 10, 2002. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Princeton BioMeditech Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 2002
- Date Received
- December 10, 2001
- 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