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FDA 510(k)

CD2 MONOCLONAL ANTIBODIES

K-Number: K914846 · 1992-06-19

ApplicantGen Trak, Inc.
Decision Date1992-06-19
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CD2 MONOCLONAL ANTIBODIES is the device name listed in this FDA 510(k) record. The listed applicant is Gen Trak, Inc.. It received FDA 510(k) clearance on 1992-06-19 under 510(k) number K914846. 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 CD2 MONOCLONAL ANTIBODIES?

CD2 MONOCLONAL ANTIBODIES is a medical device that received FDA 510(k) clearance on 1992-06-19. The listed applicant is Gen Trak, Inc.. The 510(k) number is K914846.

When did CD2 MONOCLONAL ANTIBODIES receive FDA 510(k) clearance?

CD2 MONOCLONAL ANTIBODIES received FDA 510(k) clearance on 1992-06-19, under 510(k) number K914846.

Who is the listed applicant for CD2 MONOCLONAL ANTIBODIES?

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

What is the FDA product code for CD2 MONOCLONAL ANTIBODIES?

The FDA product code for CD2 MONOCLONAL ANTIBODIES is GKZ.

Related Clinical Trials

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Other records listing Gen Trak, Inc. 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.

K922085MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOMK922084MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOMK914848CD4 MONOCLONAL ANTIBODIESK914847CD8 MONOCLONAL ANTIBODIES

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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