K994409 is an FDA 510(k) clearance for the INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST. This device is classified as a Liquid Chromatography, Morphine (Class II - Special Controls, product code DPK).
Submitted by Alfa Scientific Designs, Inc. (San Diego, US). The FDA issued a Cleared decision on July 10, 2000, 195 days after receiving the submission on December 28, 1999.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3640.
| 510(k) Number | K994409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 1999 |
| Decision Date | July 10, 2000 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DPK — Liquid Chromatography, Morphine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3640 |