FDA 510(k)

FACTOR XII DEFICIENT PLASMA B12D

K-Number: K843451 · 1984-11-19

Decision Date1984-11-19

Product CodeGGP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

FACTOR XII DEFICIENT PLASMA B12D 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 K843451. 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 XII DEFICIENT PLASMA B12D?

FACTOR XII DEFICIENT PLASMA B12D 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 K843451.

When did FACTOR XII DEFICIENT PLASMA B12D receive FDA 510(k) clearance?

FACTOR XII DEFICIENT PLASMA B12D received FDA 510(k) clearance on 1984-11-19, under 510(k) number K843451.

Who is the listed applicant for FACTOR XII DEFICIENT PLASMA B12D?

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 XII DEFICIENT PLASMA B12D?

The FDA product code for FACTOR XII DEFICIENT PLASMA B12D 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.