OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)— 510(k) K122759
Substantially EquivalentOmega Laboratories, Inc.
FDA 510(k) clearance K122759 for OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA), Substantially Equivalent on 2012-12-05. Applicant: Omega Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Omega Laboratories, Inc.
- Product code
- Code LDJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3870
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mogadore, OH, US
Recent devices under product code LDJ
view all- K232732 — Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50
- K232604 — LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)
- K223162 — Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT
- K192515 — BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
- K153741 — CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test
More clearances from Omega Laboratories, Inc.
view all- K142855 — Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA)
- K140671 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE
- K131128 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
- K131181 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE
- K112808 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
Data sourced from openFDA. This site is unofficial and independent of the FDA.