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FDA 510(k)

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES

K-Number: K103161 · 2011-12-13

ApplicantOmega Laboratories, Inc.
Decision Date2011-12-13
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES is the device name listed in this FDA 510(k) record. The listed applicant is Omega Laboratories, Inc.. It received FDA 510(k) clearance on 2011-12-13 under 510(k) number K103161. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES?

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES is a medical device that received FDA 510(k) clearance on 2011-12-13. The listed applicant is Omega Laboratories, Inc.. The 510(k) number is K103161.

When did OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES receive FDA 510(k) clearance?

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES received FDA 510(k) clearance on 2011-12-13, under 510(k) number K103161.

Who is the listed applicant for OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES?

The FDA 510(k) record lists Omega Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES?

The FDA product code for OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES is DJG.

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Other records listing Omega Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131128OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITESK131181OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINEK122759OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)K112808OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITESK101973OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)K101059OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE

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Related Devices (Code: DJG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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