The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Coc-150 One Step Cocaine Test Strip & Acon Coc-150 One Step Cocaine Test Device.
| Device ID | K032903 |
| 510k Number | K032903 |
| Device Name: | ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Edward Tung |
| Correspondent | Edward Tung ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-17 |
| Decision Date | 2004-02-17 |
| Summary: | summary |