K003557 is an FDA 510(k) clearance for the ACON THC ONE STEP MARIJUANA TEST STRIP(URINE). This device is classified as a Enzyme Immunoassay, Cannabinoids (Class II - Special Controls, product code LDJ).
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on March 15, 2001, 118 days after receiving the submission on November 17, 2000.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K003557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2000 |
| Decision Date | March 15, 2001 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LDJ — Enzyme Immunoassay, Cannabinoids |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |