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FDA 510(k)

APTT-ES REAGENT

K-Number: K934351 · 1993-12-06

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1993-12-06
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

APTT-ES 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 1993-12-06 under 510(k) number K934351. 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-ES REAGENT?

APTT-ES REAGENT is a medical device that received FDA 510(k) clearance on 1993-12-06. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K934351.

When did APTT-ES REAGENT receive FDA 510(k) clearance?

APTT-ES REAGENT received FDA 510(k) clearance on 1993-12-06, under 510(k) number K934351.

Who is the listed applicant for APTT-ES 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-ES REAGENT?

The FDA product code for APTT-ES 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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