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FDA 510(k)

FACTOR IX DEFICIENT PLASMA

K-Number: K893524 · 1989-06-23

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

Device Summary

FACTOR IX 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 K893524. 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 IX DEFICIENT PLASMA?

FACTOR IX 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 K893524.

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

FACTOR IX DEFICIENT PLASMA received FDA 510(k) clearance on 1989-06-23, under 510(k) number K893524.

Who is the listed applicant for FACTOR IX 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 IX DEFICIENT PLASMA?

The FDA product code for FACTOR IX 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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