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FDA 510(k)

PLATELETS/CU MM

K-Number: K780577 · 1978-05-19

Decision Date1978-05-19
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLATELETS/CU MM 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 1978-05-19 under 510(k) number K780577. 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 PLATELETS/CU MM?

PLATELETS/CU MM is a medical device that received FDA 510(k) clearance on 1978-05-19. The listed applicant is Geometric Data, Div. Smithkline Corp.. The 510(k) number is K780577.

When did PLATELETS/CU MM receive FDA 510(k) clearance?

PLATELETS/CU MM received FDA 510(k) clearance on 1978-05-19, under 510(k) number K780577.

Who is the listed applicant for PLATELETS/CU MM?

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 PLATELETS/CU MM?

The FDA product code for PLATELETS/CU MM is GKZ.

Related Clinical Trials

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.

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.

View all 18 devices →

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.

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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