The following data is part of a premarket notification filed by Applied Dna Technologies, Inc. with the FDA for Bionexa Single And Multi-strip Cassette/dipstick Doa Screen Panels ( Amp, Bar, Bzo, Coc, Met, Mtd, Mor, Pcp, Tca, Thc,.
| Device ID | K080467 |
| 510k Number | K080467 |
| Device Name: | BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC, |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | APPLIED DNA TECHNOLOGIES, INC. 26251 VERONA PLACE Mission Viejo, CA 92692 |
| Contact | Feng Yu-lee |
| Correspondent | Feng Yu-lee APPLIED DNA TECHNOLOGIES, INC. 26251 VERONA PLACE Mission Viejo, CA 92692 |
| Product Code | LDJ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | DNK |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-21 |
| Decision Date | 2008-11-25 |
| Summary: | summary |