K101059 is an FDA 510(k) clearance for the OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE. This device is classified as a Enzyme Immunoassay, Phencyclidine.
Submitted by Omega Laboratories, Inc. (South Lyon, US). The FDA issued a Cleared decision on July 12, 2010, 88 days after receiving the submission on April 15, 2010.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K101059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 2010 |
| Decision Date | July 12, 2010 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |