FDA 510(k)

HEMATRAK

K-Number: K770680 · 1977-07-01

ApplicantGeometric Data, Div. Smithkline Corp.

Decision Date1977-07-01

Product CodeGKZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

HEMATRAK 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 1977-07-01 under 510(k) number K770680. 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?

HEMATRAK is a medical device that received FDA 510(k) clearance on 1977-07-01. The listed applicant is Geometric Data, Div. Smithkline Corp.. The 510(k) number is K770680.

When did HEMATRAK receive FDA 510(k) clearance?

HEMATRAK received FDA 510(k) clearance on 1977-07-01, under 510(k) number K770680.

Who is the listed applicant for HEMATRAK?

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?

The FDA product code for HEMATRAK is GKZ.

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Other records listing Geometric Data, Div. Smithkline Corp. as applicant

K841852AUTOLYZER 800 K811534HEMASPINNER K791041HEMATRAK ABNORMAL RECOGNITION K791108CONTEXT FILTER K790816HEMATRAK MODEL 480 K790042STAIN, HEMASTAIN RETIC

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Related Devices (Code: GKZ)

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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.