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FDA 510(k)

STAGO FACTOR II-DEFICIENT PLASMA

K-Number: K934606 · 1994-03-01

ApplicantAmerican Bioproducts Co.
Decision Date1994-03-01
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STAGO FACTOR II-DEFICIENT PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is American Bioproducts Co.. It received FDA 510(k) clearance on 1994-03-01 under 510(k) number K934606. 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 STAGO FACTOR II-DEFICIENT PLASMA?

STAGO FACTOR II-DEFICIENT PLASMA is a medical device that received FDA 510(k) clearance on 1994-03-01. The listed applicant is American Bioproducts Co.. The 510(k) number is K934606.

When did STAGO FACTOR II-DEFICIENT PLASMA receive FDA 510(k) clearance?

STAGO FACTOR II-DEFICIENT PLASMA received FDA 510(k) clearance on 1994-03-01, under 510(k) number K934606.

Who is the listed applicant for STAGO FACTOR II-DEFICIENT PLASMA?

The FDA 510(k) record lists American Bioproducts Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STAGO FACTOR II-DEFICIENT PLASMA?

The FDA product code for STAGO FACTOR II-DEFICIENT PLASMA is 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.

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