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FDA 510(k)

HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION

K-Number: K904454 · 1990-12-17

ApplicantInternational Technidyne Corp.
Decision Date1990-12-17
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCHRON(R) PROTHROMBIN TIME/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 1990-12-17 under 510(k) number K904454. 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 HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION?

HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION is a medical device that received FDA 510(k) clearance on 1990-12-17. The listed applicant is International Technidyne Corp.. The 510(k) number is K904454.

When did HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION receive FDA 510(k) clearance?

HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION received FDA 510(k) clearance on 1990-12-17, under 510(k) number K904454.

Who is the listed applicant for HEMOCHRON(R) PROTHROMBIN TIME/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 HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION?

The FDA product code for HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION is GJS.

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Other records listing International Technidyne Corp. as applicant

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Related Devices (Code: GJS)

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.

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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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