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FDA 510(k)

CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA

K-Number: K924396 · 1993-05-21

ApplicantBehring Diagnostics, Inc.
Decision Date1993-05-21
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CLOTTING FACTOR-VIII-IX-XI-XII 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 1993-05-21 under 510(k) number K924396. 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-VIII-IX-XI-XII DEFICIENT PLASMA?

CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA is a medical device that received FDA 510(k) clearance on 1993-05-21. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K924396.

When did CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA receive FDA 510(k) clearance?

CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA received FDA 510(k) clearance on 1993-05-21, under 510(k) number K924396.

Who is the listed applicant for CLOTTING FACTOR-VIII-IX-XI-XII 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-VIII-IX-XI-XII DEFICIENT PLASMA?

The FDA product code for CLOTTING FACTOR-VIII-IX-XI-XII 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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