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FDA 510(k)

HEMOCHRON CITRATE APTT

K-Number: K972831 · 1997-11-20

ApplicantInternational Technidyne Corp.
Decision Date1997-11-20
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCHRON CITRATE APTT 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 1997-11-20 under 510(k) number K972831. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCHRON CITRATE APTT?

HEMOCHRON CITRATE APTT is a medical device that received FDA 510(k) clearance on 1997-11-20. The listed applicant is International Technidyne Corp.. The 510(k) number is K972831.

When did HEMOCHRON CITRATE APTT receive FDA 510(k) clearance?

HEMOCHRON CITRATE APTT received FDA 510(k) clearance on 1997-11-20, under 510(k) number K972831.

Who is the listed applicant for HEMOCHRON CITRATE APTT?

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 CITRATE APTT?

The FDA product code for HEMOCHRON CITRATE APTT is GFO.

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Other records listing International Technidyne Corp. as applicant

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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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