FDA 510(k)

FACTOR XI DEFICIENT PLASMA

K-Number: K900411 · 1990-03-06

Decision Date1990-03-06

Product CodeGJT

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

FACTOR XI 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 K900411. 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 XI DEFICIENT PLASMA?

FACTOR XI 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 K900411.

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

FACTOR XI DEFICIENT PLASMA received FDA 510(k) clearance on 1990-03-06, under 510(k) number K900411.

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

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

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Other records listing Sigma Chemical Co. as applicant

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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.