The following data is part of a premarket notification filed by Omega Laboratories, Inc. with the FDA for Omega Laboratories Hair Drug Screening Assay For Methamphetamine And 4-methylenedioxymethamphetamine (mdma).
| Device ID | K101973 |
| 510k Number | K101973 |
| Device Name: | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA) |
| Classification | Gas Chromatography, Methamphetamine |
| Applicant | OMEGA LABORATORIES, INC. PO BOX 506 South Lyon, MI 48178 |
| Contact | Robert J Bard |
| Correspondent | Robert J Bard OMEGA LABORATORIES, INC. PO BOX 506 South Lyon, MI 48178 |
| Product Code | LAF |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-13 |
| Decision Date | 2011-08-16 |
| Summary: | summary |