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FDA 510(k)

THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO

K-Number: K110616 · 2011-06-29

ApplicantMicrogenics Corp.
Decision Date2011-06-29
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 2011-06-29 under 510(k) number K110616. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO?

THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO is a medical device that received FDA 510(k) clearance on 2011-06-29. The listed applicant is Microgenics Corp.. The 510(k) number is K110616.

When did THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO receive FDA 510(k) clearance?

THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO received FDA 510(k) clearance on 2011-06-29, under 510(k) number K110616.

Who is the listed applicant for THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO?

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 MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO?

The FDA product code for THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO is JJY.

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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 ASSAYK101746THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAYK101742THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAYK101752THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS

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Related Devices (Code: JJY)

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.

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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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