Protein S Control Plasma

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K870917 ↗

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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See all devices from American Bioproducts Co. →

• What is Protein S Control Plasma used for?

  Protein S Control Plasma is used as a control material for laboratory assays that measure protein S levels in blood plasma, serving as a reference for qualitative and quantitative factor deficiency testing in hematology.

• How is Protein S Control Plasma supplied?

  The device is supplied as a plasma control material intended for laboratory use. The data does not specify whether it is single-use or reusable.

• What is the regulatory status of Protein S Control Plasma?

  Protein S Control Plasma is regulated under FDA 510(k) clearance with K number K870917, received on March 6, 1987, and determined to be substantially equivalent on April 23, 1987.

• What is the manufacturer of Protein S Control Plasma?

  Protein S Control Plasma is manufactured by American Bioproducts Co., located at 601 N. Jefferson Rd., Parsippany, NJ 07054.