Submission Details
| 510(k) Number | K140671 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 18, 2014 |
| Decision Date | January 08, 2015 |
| Days to Decision | 296 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE
Jan 2015
Decision
296d
Days
Class 2
Risk
About This 510(k) Submission
K140671 is an FDA 510(k) clearance for the OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Omega Laboratories, Inc. (Mogadore, US). The FDA issued a Cleared decision on January 8, 2015, 296 days after receiving the submission on March 18, 2014. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.
Device Classification
| Product Code | DJG — Enzyme Immunoassay, Opiates |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3650 |
Manufacturer
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