FDA 510(k)

FACTOR VIII DEFICIENT PLASMA #B8D

K-Number: K812431 · 1981-09-23

Decision Date1981-09-23

Product CodeGGP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

FACTOR VIII DEFICIENT PLASMA #B8D 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 1981-09-23 under 510(k) number K812431. 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 VIII DEFICIENT PLASMA #B8D?

FACTOR VIII DEFICIENT PLASMA #B8D is a medical device that received FDA 510(k) clearance on 1981-09-23. The listed applicant is Sigma Chemical Co.. The 510(k) number is K812431.

When did FACTOR VIII DEFICIENT PLASMA #B8D receive FDA 510(k) clearance?

FACTOR VIII DEFICIENT PLASMA #B8D received FDA 510(k) clearance on 1981-09-23, under 510(k) number K812431.

Who is the listed applicant for FACTOR VIII DEFICIENT PLASMA #B8D?

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 VIII DEFICIENT PLASMA #B8D?

The FDA product code for FACTOR VIII DEFICIENT PLASMA #B8D 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.