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FDA 510(k)

THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY

K-Number: K101746 · 2011-04-08

ApplicantMicrogenics Corp.
Decision Date2011-04-08
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 2011-04-08 under 510(k) number K101746. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY?

THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY is a medical device that received FDA 510(k) clearance on 2011-04-08. The listed applicant is Microgenics Corp.. The 510(k) number is K101746.

When did THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY receive FDA 510(k) clearance?

THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY received FDA 510(k) clearance on 2011-04-08, under 510(k) number K101746.

Who is the listed applicant for THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY?

The FDA 510(k) record lists Microgenics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY?

The FDA product code for THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY is LCM.

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Other records listing Microgenics Corp. 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.

K122766THERMO SCIENTIFIC QMS EVEROLIMUS ASSAYK123343THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORSK123271ABBOTT PHENOBARBITAL ASSAYK110616THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PROK101754THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAYK101752THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS

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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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