FDA 510(k)

FACTOR VII DEFICIENT PLASMA

K-Number: K791794 · 1979-10-01

Decision Date1979-10-01

Product CodeGGP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

FACTOR VII DEFICIENT PLASMA 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 1979-10-01 under 510(k) number K791794. 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 VII DEFICIENT PLASMA?

FACTOR VII DEFICIENT PLASMA is a medical device that received FDA 510(k) clearance on 1979-10-01. The listed applicant is Sigma Chemical Co.. The 510(k) number is K791794.

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

FACTOR VII DEFICIENT PLASMA received FDA 510(k) clearance on 1979-10-01, under 510(k) number K791794.

Who is the listed applicant for FACTOR VII DEFICIENT PLASMA?

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 VII DEFICIENT PLASMA?

The FDA product code for FACTOR VII DEFICIENT PLASMA is GGP.

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Other records listing Sigma Chemical Co. as applicant

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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.