K001356 is an FDA 510(k) clearance for the ONTRAK TESTCUP PRO-5, MODEL 1986678. This device is classified as a Thin Layer Chromatography, Methamphetamine (Class II - Special Controls, product code DJC).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 10, 2000, 73 days after receiving the submission on April 28, 2000.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3610.
| 510(k) Number | K001356 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2000 |
| Decision Date | July 10, 2000 |
| Days to Decision | 73 days |
| Submission Type | Special |
| 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 |