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FDA 510(k)

FACTOR VII DEFICIENT PLASMA

K-Number: K893535 · 1989-06-23

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

Device Summary

FACTOR VII 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 K893535. 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 VII DEFICIENT PLASMA?

FACTOR VII 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 K893535.

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

FACTOR VII DEFICIENT PLASMA received FDA 510(k) clearance on 1989-06-23, under 510(k) number K893535.

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

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

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Other records listing Medical Diagnostic Technologies, Inc. as applicant

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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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