The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Thc One Step Marijuana Test Strip(urine);acon Thc One Step Marijuana Test Device (urine).
| Device ID | K003557 |
| 510k Number | K003557 |
| Device Name: | ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE) |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | ACON LABORATORIES, INC. 11175 FLINTKOTE AVE., #F San Diego, CA 92121 |
| Contact | Nora C.r. York |
| Correspondent | Nora C.r. York ACON LABORATORIES, INC. 11175 FLINTKOTE AVE., #F San Diego, CA 92121 |
| Product Code | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-17 |
| Decision Date | 2001-03-15 |