K013180 is an FDA 510(k) clearance for the RAPIDONE-ECSTASY TEST. This device is classified as a Thin Layer Chromatography, Methamphetamine (Class II - Special Controls, product code DJC).
Submitted by American Bio Medica Corp. (Columbia, US). The FDA issued a Cleared decision on November 26, 2001, 63 days after receiving the submission on September 24, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3610.
| 510(k) Number | K013180 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2001 |
| Decision Date | November 26, 2001 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DJC — Thin Layer Chromatography, Methamphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3610 |