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FDA 510(k)

ABBOTT PHENOBARBITAL ASSAY

K-Number: K123271 · 2013-04-26

ApplicantMicrogenics Corp.
Decision Date2013-04-26
Product CodeDLZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABBOTT PHENOBARBITAL 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 2013-04-26 under 510(k) number K123271. The device is classified under product code DLZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT PHENOBARBITAL ASSAY?

ABBOTT PHENOBARBITAL ASSAY is a medical device that received FDA 510(k) clearance on 2013-04-26. The listed applicant is Microgenics Corp.. The 510(k) number is K123271.

When did ABBOTT PHENOBARBITAL ASSAY receive FDA 510(k) clearance?

ABBOTT PHENOBARBITAL ASSAY received FDA 510(k) clearance on 2013-04-26, under 510(k) number K123271.

Who is the listed applicant for ABBOTT PHENOBARBITAL 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 ABBOTT PHENOBARBITAL ASSAY?

The FDA product code for ABBOTT PHENOBARBITAL ASSAY is DLZ.

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Other records listing Microgenics Corp. as applicant

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K122766THERMO SCIENTIFIC QMS EVEROLIMUS ASSAYK123343THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORSK110616THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PROK101754THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAYK101746THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAYK101742THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY

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Related Devices (Code: DLZ)

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.

K210858VITROS Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc.K081231ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33Abbott LaboratoriesK071644ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620Roche Diagnostics Corp.K011303RANDOX PHENOBARBITALRandox Laboratories, Ltd.K011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229Syva Co.K000012IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5Diagnostic Products Corp.

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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