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FDA 510(k)

HEMATRAK RBC MORPHOLOGY

K-Number: K761207 · 1977-10-18

ApplicantGeometric Data, Div. Smithkline Corp.
Decision Date1977-10-18
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMATRAK RBC MORPHOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Geometric Data, Div. Smithkline Corp.. It received FDA 510(k) clearance on 1977-10-18 under 510(k) number K761207. 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 HEMATRAK RBC MORPHOLOGY?

HEMATRAK RBC MORPHOLOGY is a medical device that received FDA 510(k) clearance on 1977-10-18. The listed applicant is Geometric Data, Div. Smithkline Corp.. The 510(k) number is K761207.

When did HEMATRAK RBC MORPHOLOGY receive FDA 510(k) clearance?

HEMATRAK RBC MORPHOLOGY received FDA 510(k) clearance on 1977-10-18, under 510(k) number K761207.

Who is the listed applicant for HEMATRAK RBC MORPHOLOGY?

The FDA 510(k) record lists Geometric Data, Div. Smithkline Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMATRAK RBC MORPHOLOGY?

The FDA product code for HEMATRAK RBC MORPHOLOGY is GKZ.

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Other records listing Geometric Data, Div. Smithkline 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.

K841852AUTOLYZER 800K811534HEMASPINNERK791041HEMATRAK ABNORMAL RECOGNITIONK791108CONTEXT FILTERK790816HEMATRAK MODEL 480K790042STAIN, HEMASTAIN RETIC

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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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