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FDA 510(k)

HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT

K-Number: K924638 · 1993-01-14

ApplicantInternational Technidyne Corp.
Decision Date1993-01-14
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-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 1993-01-14 under 510(k) number K924638. 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 DIRECT DRAW APTT/FAC VI VACU-APTT?

HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT is a medical device that received FDA 510(k) clearance on 1993-01-14. The listed applicant is International Technidyne Corp.. The 510(k) number is K924638.

When did HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT receive FDA 510(k) clearance?

HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT received FDA 510(k) clearance on 1993-01-14, under 510(k) number K924638.

Who is the listed applicant for HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-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 DIRECT DRAW APTT/FAC VI VACU-APTT?

The FDA product code for HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT 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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