Submission Details
| 510(k) Number | K142855 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 30, 2014 |
| Decision Date | July 28, 2015 |
| Days to Decision | 301 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA)
Jul 2015
Decision
301d
Days
Class 2
Risk
About This 510(k) Submission
K142855 is an FDA 510(k) clearance for the Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA), a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Omega Laboratories, Inc. (Mogadore, US). The FDA issued a Cleared decision on July 28, 2015, 301 days after receiving the submission on September 30, 2014. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.
Device Classification
| Product Code | DKZ — Enzyme Immunoassay, Amphetamine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3100 |
Manufacturer
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