The following data is part of a premarket notification filed by Applied Dna Technologies, Inc. with the FDA for Accustep Doa Single And Multi-strip Screen Panels.
| Device ID | K061005 |
| 510k Number | K061005 |
| Device Name: | ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS |
| Classification | Enzyme Immunoassay, Amphetamine |
| 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 | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DNK |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-11 |
| Decision Date | 2006-10-04 |
| Summary: | summary |