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FDA 510(k)

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE

K-Number: K101059 · 2010-07-12

ApplicantOmega Laboratories, Inc.
Decision Date2010-07-12
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE 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 2010-07-12 under 510(k) number K101059. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE is a medical device that received FDA 510(k) clearance on 2010-07-12. The listed applicant is Omega Laboratories, Inc.. The 510(k) number is K101059.

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

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE received FDA 510(k) clearance on 2010-07-12, under 510(k) number K101059.

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

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 PHENCYCLIDINE?

The FDA product code for OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE is LCM.

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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 METABOLITESK103161OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATESK101973OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)

View all 7 devices →

Related Devices (Code: LCM)

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.

K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairPsychemedics CorporationK203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis CorporationK181135Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis CorporationK163220Atellica CH Phencyclidine (Pcp)Siemens Healthcare Diagnostics, Inc.K131181OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINEOmega Laboratories, Inc.K122703RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTORBiophor Diagnostics, 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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