FDA 510(k)

FACTOR XII DEFICIENT PLASMA

K-Number: K900412 · 1990-03-06

Decision Date1990-03-06

Product CodeGJT

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

FACTOR XII 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 1990-03-06 under 510(k) number K900412. 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 FACTOR XII DEFICIENT PLASMA?

FACTOR XII DEFICIENT PLASMA is a medical device that received FDA 510(k) clearance on 1990-03-06. The listed applicant is Sigma Chemical Co.. The 510(k) number is K900412.

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

FACTOR XII DEFICIENT PLASMA received FDA 510(k) clearance on 1990-03-06, under 510(k) number K900412.

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

The FDA product code for FACTOR XII DEFICIENT PLASMA is GJT.

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Other records listing Sigma Chemical Co. as applicant

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Related Devices (Code: GJT)

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Official Source

View on FDA Database →

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