Cryp Check In-Vitro Coagulation Control System

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

510(k) Number

K922887 ↗

FDA Product Code

GGN

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Saf Fecal Collection Kit

  Class I

  FDA 510(k) K885244 Active Cleared 21 Mar 1989

• Cryo Check Factor V Deficient Plasma

  Class II

  FDA 510(k) K971223 Active Cleared 22 Jul 1997

• Cryo Check Factor XI Deficient Plasma, Model FDP11-10 (1.OML) and FDP11-15 (1.5ml)

  Class II

  FDA 510(k) K981173 Active Cleared 13 Jan 1999

• Cryo Check Factor XII Deficient Plasma Model FDP12-10 (1.0ml) and FDP12-15 (1.5ml)

  Class II

  FDA 510(k) K981174 Active Cleared 13 Jan 1999

• Cryo Check Apc Resistant Plasma

  Class II

  FDA 510(k) K971222 Active Cleared 19 Aug 1997

• Aptt Reagent

  Class II

  FDA 510(k) K884856 Active Cleared 30 Jan 1989

See all devices from Precision Biologicals, Inc. →

• What is the primary purpose of the Cryp Check In-Vitro Coagulation Control System?

  This device is designed to function as a control for in-vitro coagulation testing procedures, helping to ensure the accuracy and reliability of laboratory coagulation results.

• Has this device received regulatory authorization?

  Yes, the Cryp Check In-Vitro Coagulation Control System has received FDA 510(k) clearance under K-number K922887.

• What regulatory classification does this device fall under?

  The device is identified under FDA regulation number 864.5425, which pertains to plasma coagulation control devices within the hematology medical specialty.