Immunoadsorbed Factor X Deficient Plasma (Human)

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K870353 ↗

FDA Product Code

GGP

Device Class

Class II

Regulation

21 CFR Part 864.7290

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• Lactate Reagent

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  FDA 510(k) K840778 Active Cleared 13 Apr 1984

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• Uric Acid Reagent

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  FDA 510(k) K840781 Active Cleared 13 Apr 1984

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