Dade Immunoadsorbed Factor IX Deficient Plasma

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K915411 ↗

FDA Product Code

GJT

Device Class

Class II

Regulation

21 CFR Part 864.7290

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Baxter Diagnostics, Inc. →

• What is the primary use of Dade Immunoadsorbed Factor IX Deficient Plasma?

  This device is a coagulation factor deficient plasma product specifically designed for hematology applications. It is utilized by clinical laboratories for the assessment of coagulation factors in patient samples.

• How is this device regulated?

  Dade Immunoadsorbed Factor IX Deficient Plasma is classified as a Class II medical device under 21 CFR 864.7290. It has received FDA 510(k) clearance, confirming it is substantially equivalent to predicate devices for its intended use in hematology.

• What is the product code for this device?

  The device is identified by the product code GJT, which corresponds to coagulation factor deficient plasma. This classification is used by the FDA to categorize the device within the hematology medical specialty.