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FDA 510(k)

THERMO SCIENTIFIC CYTO-CAL COUNT TUBES

K-Number: K090810 · 2009-09-18

ApplicantMicrogenics Corp.
Decision Date2009-09-18
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THERMO SCIENTIFIC CYTO-CAL COUNT TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 2009-09-18 under 510(k) number K090810. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMO SCIENTIFIC CYTO-CAL COUNT TUBES?

THERMO SCIENTIFIC CYTO-CAL COUNT TUBES is a medical device that received FDA 510(k) clearance on 2009-09-18. The listed applicant is Microgenics Corp.. The 510(k) number is K090810.

When did THERMO SCIENTIFIC CYTO-CAL COUNT TUBES receive FDA 510(k) clearance?

THERMO SCIENTIFIC CYTO-CAL COUNT TUBES received FDA 510(k) clearance on 2009-09-18, under 510(k) number K090810.

Who is the listed applicant for THERMO SCIENTIFIC CYTO-CAL COUNT TUBES?

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 CYTO-CAL COUNT TUBES?

The FDA product code for THERMO SCIENTIFIC CYTO-CAL COUNT TUBES is GKZ.

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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 PROK101742THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAYK101752THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS

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Related Devices (Code: GKZ)

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.

K260781Yumizen H550HORIBA ABX SASK253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, 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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