510(k) K080467
K080467 is an FDA 510(k) premarket notification submitted by Applied Dna Technologies, Inc. for the device "BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,". The FDA issued a decision of Substantially Equivalent on November 25, 2008. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Applied Dna Technologies, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 2008
- Date Received
- February 21, 2008
- 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