Sta-Coag Control [P] Plus Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K952338 ↗

FDA Product Code

GGC

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from American Bioproducts Co. →

• What is the STA-COAG CONTROL [P] PLUS KIT used for?

  The STA-COAG CONTROL [P] PLUS KIT is a Class 2 Hematology device that serves as a control for coagulation testing in laboratory settings. It is designed to ensure the proper functioning of coagulation testing equipment.

• How is the STA-COAG CONTROL [P] PLUS KIT supplied?

  The kit is supplied by American Bioproducts Co. The device data does not specify whether it is single-use or reusable, nor does it provide information about sterility or storage conditions.

• What is the regulatory status of the STA-COAG CONTROL [P] PLUS KIT?

  The STA-COAG CONTROL [P] PLUS KIT was cleared through the Traditional 510(k) pathway on September 21, 1995, with the K number K952338. It is classified as a Class 2 Hematology device.

• What are the specifications of the STA-COAG CONTROL [P] PLUS KIT?

  The device is a control for coagulation testing with the product code GGC. It is described as a summary with a decision description of 'Substantially Equivalent' and was reviewed by the Hematology advisory committee.