FDA 510(k)

APTT BY HEMOCHRON(R)

K-Number: K892209 · 1989-06-22

Decision Date1989-06-22

Product CodeGFO

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

APTT BY HEMOCHRON(R) is the device name listed in this FDA 510(k) record. The listed applicant is Intensive Technology, Inc.. It received FDA 510(k) clearance on 1989-06-22 under 510(k) number K892209. 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 APTT BY HEMOCHRON(R)?

APTT BY HEMOCHRON(R) is a medical device that received FDA 510(k) clearance on 1989-06-22. The listed applicant is Intensive Technology, Inc.. The 510(k) number is K892209.

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

APTT BY HEMOCHRON(R) received FDA 510(k) clearance on 1989-06-22, under 510(k) number K892209.

Who is the listed applicant for APTT BY HEMOCHRON(R)?

The FDA 510(k) record lists Intensive Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APTT BY HEMOCHRON(R)?

The FDA product code for APTT BY HEMOCHRON(R) 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.