Submission Details
| 510(k) Number | K131181 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 25, 2013 |
| Decision Date | June 25, 2013 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE
Jun 2013
Decision
61d
Days
—
Risk
About This 510(k) Submission
K131181 is an FDA 510(k) clearance for the OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE, a Enzyme Immunoassay, Phencyclidine, submitted by Omega Laboratories, Inc. (Mogadore, US). The FDA issued a Cleared decision on June 25, 2013, 61 days after receiving the submission on April 25, 2013. This device falls under the Toxicology review panel.
Device Classification
| Product Code | LCM — Enzyme Immunoassay, Phencyclidine |
| Device Class | — |
Manufacturer
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