FDA 510(k)

FACTOR IX DEFICIENT PLASMA, B9D -

K-Number: K843215 · 1984-11-19

Decision Date1984-11-19

Product CodeGGP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

FACTOR IX DEFICIENT PLASMA, B9D - is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1984-11-19 under 510(k) number K843215. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FACTOR IX DEFICIENT PLASMA, B9D -?

FACTOR IX DEFICIENT PLASMA, B9D - is a medical device that received FDA 510(k) clearance on 1984-11-19. The listed applicant is Sigma Chemical Co.. The 510(k) number is K843215.

When did FACTOR IX DEFICIENT PLASMA, B9D - receive FDA 510(k) clearance?

FACTOR IX DEFICIENT PLASMA, B9D - received FDA 510(k) clearance on 1984-11-19, under 510(k) number K843215.

Who is the listed applicant for FACTOR IX DEFICIENT PLASMA, B9D -?

The FDA 510(k) record lists Sigma Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FACTOR IX DEFICIENT PLASMA, B9D -?

The FDA product code for FACTOR IX DEFICIENT PLASMA, B9D - is GGP.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.