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FDA 510(k)

IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN

K-Number: K880874 · 1988-03-17

ApplicantBaxter Healthcare Corp
Decision Date1988-03-17
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1988-03-17 under 510(k) number K880874. 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 IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN?

IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN is a medical device that received FDA 510(k) clearance on 1988-03-17. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K880874.

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

IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN received FDA 510(k) clearance on 1988-03-17, under 510(k) number K880874.

Who is the listed applicant for IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN?

The FDA product code for IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN is GJT.

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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.

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