The following data is part of a premarket notification filed by Omega Laboratories, Inc. with the FDA for Omega Laboratories Hair Drug Screening Assay Methamphetamine (meth) And -3, 4-methylenedioxymethamphetamine (mdma).
| Device ID | K142855 |
| 510k Number | K142855 |
| Device Name: | Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) And -3, 4-methylenedioxymethamphetamine (MDMA) |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | Omega Laboratories, Inc. 400 N. Cleveland Ave. Mogadore, OH 44260 |
| Contact | William Corl |
| Correspondent | Robert J Bard Omega Laboratories, Inc. 400 N. Cleveland Ave. Mogadore, OH 44260 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-30 |
| Decision Date | 2015-07-28 |
| Summary: | summary |