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FDA 510(k)

MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM

K-Number: K922084 · 1992-07-28

ApplicantGen Trak, Inc.
Decision Date1992-07-28
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM 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 1992-07-28 under 510(k) number K922084. 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 MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM?

MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM is a medical device that received FDA 510(k) clearance on 1992-07-28. The listed applicant is Gen Trak, Inc.. The 510(k) number is K922084.

When did MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM receive FDA 510(k) clearance?

MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM received FDA 510(k) clearance on 1992-07-28, under 510(k) number K922084.

Who is the listed applicant for MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM?

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 MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM?

The FDA product code for MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM 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 CYTOMK914846CD2 MONOCLONAL ANTIBODIESK914848CD4 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

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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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