K143187 is an FDA 510(k) clearance for the Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card). This device is classified as a Enzyme Immunoassay, Opiates (Class II - Special Controls, product code DJG).
Submitted by Healgen Scientific, LLC (Bellaire, US). The FDA issued a Cleared decision on January 27, 2015, 83 days after receiving the submission on November 5, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K143187 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2014 |
| Decision Date | January 27, 2015 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DJG — Enzyme Immunoassay, Opiates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3650 |