OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES— 510(k) K103161
Substantially EquivalentOmega Laboratories, Inc.
FDA 510(k) clearance K103161 for OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, Substantially Equivalent on 2011-12-13. Applicant: Omega Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Omega Laboratories, Inc.
- Product code
- Code DJG
- Device class
- Class 2
- Regulation
- 21 CFR 862.3650
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mogadore, OH, US
Recent devices under product code DJG
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Data sourced from openFDA. This site is unofficial and independent of the FDA.