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FDA 510(k)

HEMOCHRON ONESTEP APTT TEST

K-Number: K915344 · 1992-02-11

ApplicantInternational Technidyne Corp.
Decision Date1992-02-11
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCHRON ONESTEP APTT TEST 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 1992-02-11 under 510(k) number K915344. 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 ONESTEP APTT TEST?

HEMOCHRON ONESTEP APTT TEST is a medical device that received FDA 510(k) clearance on 1992-02-11. The listed applicant is International Technidyne Corp.. The 510(k) number is K915344.

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

HEMOCHRON ONESTEP APTT TEST received FDA 510(k) clearance on 1992-02-11, under 510(k) number K915344.

Who is the listed applicant for HEMOCHRON ONESTEP APTT TEST?

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 ONESTEP APTT TEST?

The FDA product code for HEMOCHRON ONESTEP APTT TEST is GFO.

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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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