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FDA 510(k)

HEMATRAK ABNORMAL RECOGNITION

K-Number: K791041 · 1979-09-04

ApplicantGeometric Data, Div. Smithkline Corp.
Decision Date1979-09-04
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMATRAK ABNORMAL RECOGNITION 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 1979-09-04 under 510(k) number K791041. 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 ABNORMAL RECOGNITION?

HEMATRAK ABNORMAL RECOGNITION is a medical device that received FDA 510(k) clearance on 1979-09-04. The listed applicant is Geometric Data, Div. Smithkline Corp.. The 510(k) number is K791041.

When did HEMATRAK ABNORMAL RECOGNITION receive FDA 510(k) clearance?

HEMATRAK ABNORMAL RECOGNITION received FDA 510(k) clearance on 1979-09-04, under 510(k) number K791041.

Who is the listed applicant for HEMATRAK ABNORMAL RECOGNITION?

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 ABNORMAL RECOGNITION?

The FDA product code for HEMATRAK ABNORMAL RECOGNITION is GKZ.

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

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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.

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