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FDA 510(k)

COAGULATION FACTOR V DEFICIENT PLASMA

K-Number: K981709 · 1998-10-13

ApplicantDade Behring, Inc.
Decision Date1998-10-13
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAGULATION FACTOR V DEFICIENT PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 1998-10-13 under 510(k) number K981709. 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 COAGULATION FACTOR V DEFICIENT PLASMA?

COAGULATION FACTOR V DEFICIENT PLASMA is a medical device that received FDA 510(k) clearance on 1998-10-13. The listed applicant is Dade Behring, Inc.. The 510(k) number is K981709.

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

COAGULATION FACTOR V DEFICIENT PLASMA received FDA 510(k) clearance on 1998-10-13, under 510(k) number K981709.

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

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

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

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

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Official Source

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