OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)— 510(k) K101973
Substantially EquivalentOmega Laboratories, Inc.
FDA 510(k) clearance K101973 for OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA), Substantially Equivalent on 2011-08-16. Applicant: Omega Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Omega Laboratories, Inc.
- Product code
- Code LAF
- Device class
- Class 2
- Regulation
- 21 CFR 862.3610
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Lyon, MI, US
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- K131128 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
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Data sourced from openFDA. This site is unofficial and independent of the FDA.