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FDA 510(k)

CLOTTING FACTOR V DEFICIENT PLASMA

K-Number: K924394 · 1992-12-01

ApplicantBehring Diagnostics, Inc.
Decision Date1992-12-01
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CLOTTING FACTOR V DEFICIENT PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-12-01 under 510(k) number K924394. 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 CLOTTING FACTOR V DEFICIENT PLASMA?

CLOTTING FACTOR V DEFICIENT PLASMA is a medical device that received FDA 510(k) clearance on 1992-12-01. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K924394.

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

CLOTTING FACTOR V DEFICIENT PLASMA received FDA 510(k) clearance on 1992-12-01, under 510(k) number K924394.

Who is the listed applicant for CLOTTING FACTOR V DEFICIENT PLASMA?

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

What is the FDA product code for CLOTTING FACTOR V DEFICIENT PLASMA?

The FDA product code for CLOTTING 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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