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FDA 510(k)

THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY

K-Number: K122766 · 2013-08-20

ApplicantMicrogenics Corp.
Decision Date2013-08-20
Product CodeOUF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

THERMO SCIENTIFIC QMS EVEROLIMUS 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 2013-08-20 under 510(k) number K122766. The device is classified under product code OUF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY?

THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY is a medical device that received FDA 510(k) clearance on 2013-08-20. The listed applicant is Microgenics Corp.. The 510(k) number is K122766.

When did THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY receive FDA 510(k) clearance?

THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY received FDA 510(k) clearance on 2013-08-20, under 510(k) number K122766.

Who is the listed applicant for THERMO SCIENTIFIC QMS EVEROLIMUS 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 QMS EVEROLIMUS ASSAY?

The FDA product code for THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY is OUF.

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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.

K123343THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORSK123271ABBOTT PHENOBARBITAL ASSAYK110616THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PROK101754THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAYK101742THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAYK101746THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY

View all 106 devices →

Related Devices (Code: OUF)

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.

K100144THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLSMicrogenics 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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