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FDA 510(k)

APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT

K-Number: K895255 · 1989-10-06

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1989-10-06
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1989-10-06 under 510(k) number K895255. 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-P REAGENT, A PARTICLE ACTIVATED REAGENT?

APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT is a medical device that received FDA 510(k) clearance on 1989-10-06. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K895255.

When did APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT receive FDA 510(k) clearance?

APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT received FDA 510(k) clearance on 1989-10-06, under 510(k) number K895255.

Who is the listed applicant for APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT?

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

What is the FDA product code for APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT?

The FDA product code for APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT 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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