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FDA 510(k)

DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA

K-Number: K915411 · 1992-05-11

ApplicantBaxter Diagnostics, Inc.
Decision Date1992-05-11
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-05-11 under 510(k) number K915411. 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 DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA?

DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA is a medical device that received FDA 510(k) clearance on 1992-05-11. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K915411.

When did DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA receive FDA 510(k) clearance?

DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA received FDA 510(k) clearance on 1992-05-11, under 510(k) number K915411.

Who is the listed applicant for DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA?

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

What is the FDA product code for DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA?

The FDA product code for DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA is GJT.

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Other records listing Baxter Diagnostics, Inc. as applicant

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Related Devices (Code: GJT)

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Official Source

View on FDA Database →

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