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FDA 510(k)

FACTOR V DEFICIENT PLASMA

K-Number: K893533 · 1989-06-23

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1989-06-23
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FACTOR V DEFICIENT PLASMA 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 1989-06-23 under 510(k) number K893533. The device is classified under product code GJT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FACTOR V DEFICIENT PLASMA?

FACTOR V DEFICIENT PLASMA is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K893533.

When did FACTOR V DEFICIENT PLASMA receive FDA 510(k) clearance?

FACTOR V DEFICIENT PLASMA received FDA 510(k) clearance on 1989-06-23, under 510(k) number K893533.

Who is the listed applicant for FACTOR V DEFICIENT PLASMA?

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 FACTOR V DEFICIENT PLASMA?

The FDA product code for FACTOR V DEFICIENT PLASMA is GJT.

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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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