FDA 510(k)

TRAX(TM) CD4 TEST KIT

K-Number: K925255 · 1995-05-15

Decision Date1995-05-15

Product CodeGKZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

TRAX(TM) CD4 TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is T Cell Diagnostics, Inc.. It received FDA 510(k) clearance on 1995-05-15 under 510(k) number K925255. 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 TRAX(TM) CD4 TEST KIT?

TRAX(TM) CD4 TEST KIT is a medical device that received FDA 510(k) clearance on 1995-05-15. The listed applicant is T Cell Diagnostics, Inc.. The 510(k) number is K925255.

When did TRAX(TM) CD4 TEST KIT receive FDA 510(k) clearance?

TRAX(TM) CD4 TEST KIT received FDA 510(k) clearance on 1995-05-15, under 510(k) number K925255.

Who is the listed applicant for TRAX(TM) CD4 TEST KIT?

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

What is the FDA product code for TRAX(TM) CD4 TEST KIT?

The FDA product code for TRAX(TM) CD4 TEST KIT is GKZ.

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 SAS K253212XR-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.