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FDA 510(k)

PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION

K-Number: K911995 · 1991-07-17

ApplicantInternational Technidyne Corp.
Decision Date1991-07-17
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is International Technidyne Corp.. It received FDA 510(k) clearance on 1991-07-17 under 510(k) number K911995. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION?

PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-07-17. The listed applicant is International Technidyne Corp.. The 510(k) number is K911995.

When did PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION receive FDA 510(k) clearance?

PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION received FDA 510(k) clearance on 1991-07-17, under 510(k) number K911995.

Who is the listed applicant for PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION?

The FDA 510(k) record lists International Technidyne Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION?

The FDA product code for PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION is GJS.

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Related Devices (Code: GJS)

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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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