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 Cocaine And Cocaine Metabolites.
| Device ID | K131128 |
| 510k Number | K131128 |
| Device Name: | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | OMEGA LABORATORIES, INC. 400 NORTH CLEVELAND Mogadore, OH 44260 |
| Contact | Robert J Bard, Jd |
| Correspondent | Robert J Bard, Jd OMEGA LABORATORIES, INC. 400 NORTH CLEVELAND Mogadore, OH 44260 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-23 |
| Decision Date | 2013-11-13 |
| Summary: | summary |