Staclot Pnp Test Kit

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

Full name

Staclot(R) Pnp Test Kit

510(k) Number

K924370 ↗

FDA Product Code

GGW

Device Class

Class II

Regulation

21 CFR Part 864.7925

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from American Bioproducts Co. →

• What is the primary clinical use of the Staclot PNP Test Kit?

  The Staclot PNP Test Kit is designed for the laboratory assessment of coagulation parameters. It functions as a partial thromboplastin time test device to assist clinicians in evaluating blood clotting function.

• What is the regulatory status of this device?

  The Staclot PNP Test Kit has received FDA 510(k) clearance. It is classified under 21 CFR 864.7925 and is identified by product code GGW within the hematology medical specialty.

• Who is the manufacturer of the Staclot PNP Test Kit?

  The Staclot PNP Test Kit is manufactured by American Bioproducts Co., located in Parsippany, New Jersey. The device was submitted for regulatory review under K-number K924370.