The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Mdma One Step Ecstasy Test Strip & Acon Mdma One Step Ecstasy Test Device.
| Device ID | K022589 |
| 510k Number | K022589 |
| Device Name: | ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE |
| Classification | Gas Chromatography, Methamphetamine |
| 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 | LAF |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-05 |
| Decision Date | 2002-10-28 |
| Summary: | summary |