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FDA 510(k)

TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00

K-Number: K082091 · 2009-04-15

ApplicantReametrix, Inc.
Decision Date2009-04-15
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00 is the device name listed in this FDA 510(k) record. The listed applicant is Reametrix, Inc.. It received FDA 510(k) clearance on 2009-04-15 under 510(k) number K082091. 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 TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00?

TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00 is a medical device that received FDA 510(k) clearance on 2009-04-15. The listed applicant is Reametrix, Inc.. The 510(k) number is K082091.

When did TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00 receive FDA 510(k) clearance?

TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00 received FDA 510(k) clearance on 2009-04-15, under 510(k) number K082091.

Who is the listed applicant for TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00?

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

What is the FDA product code for TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00?

The FDA product code for TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00 is GKZ.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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