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FDA 510(k)

HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT

K-Number: K972866 · 1998-09-30

ApplicantInternational Technidyne Corp.
Decision Date1998-09-30
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT 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 1998-09-30 under 510(k) number K972866. 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 JR. MIOCROCOAGULATION CITRATED PT?

HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT is a medical device that received FDA 510(k) clearance on 1998-09-30. The listed applicant is International Technidyne Corp.. The 510(k) number is K972866.

When did HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT receive FDA 510(k) clearance?

HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT received FDA 510(k) clearance on 1998-09-30, under 510(k) number K972866.

Who is the listed applicant for HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT?

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 JR. MIOCROCOAGULATION CITRATED PT?

The FDA product code for HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT 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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