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FDA 510(k)

PROTHROMBIN TIME (PT) BY HEMOCHRON

K-Number: K893378 · 1989-06-22

ApplicantInternational Technidyne Corp.
Decision Date1989-06-22
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PROTHROMBIN TIME (PT) BY HEMOCHRON 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 1989-06-22 under 510(k) number K893378. 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?

PROTHROMBIN TIME (PT) BY HEMOCHRON is a medical device that received FDA 510(k) clearance on 1989-06-22. The listed applicant is International Technidyne Corp.. The 510(k) number is K893378.

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

PROTHROMBIN TIME (PT) BY HEMOCHRON received FDA 510(k) clearance on 1989-06-22, under 510(k) number K893378.

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

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?

The FDA product code for PROTHROMBIN TIME (PT) BY HEMOCHRON 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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