CRYOcheck FVIII Inhibitor Kit

Q: What is the product code of K183440?

The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.

FDA 510(k) K183440 · Precision Biologic, Inc.

Substantially Equivalent

510(k) numberK183440

Submission

Device name: CRYOcheck FVIII Inhibitor Kit
Applicant: Precision Biologic, Inc.
Darmouth, CA
Received: December 12, 2018
Decision date: March 12, 2019
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GGP – Test, Qualitative And Quantitative Factor Deficiency
Device class: Class II (moderate risk)
Regulation: 21 CFR 864.7290
Specialty: Hematology

Other 510(k)s with product code GGP

510(k)	Device	Applicant	Decision
K251440	CRYOcheck Chromogenic Factor VIIIGGP · Traditional	Precision Biologic, Inc.	08/25/2025SE
K230852	HemosIL Chromogenic Factor IXGGP · Traditional	Instrumentation Laboratory Company	12/13/2023SE
K220728	vWF AgGGP · Traditional	Siemens Healthcare Diagnostics Products GmbH	06/02/2023SE
K214002	CRYOcheck Chromogenic Factor IXGGP · Traditional	Precision Biologic, Inc.	12/23/2022SE
K223402	HemosIL von Willebrand Factor AntigenGGP · Special	Instrumentation Laboratory CO	12/09/2022SE
K200033	HemosIL von Willebrand Factor AntigenGGP · Special	Instrumentation Laboratory CO	08/19/2020SE
K193204	Cryocheck Chromogenic Factor VIIIGGP · Traditional	Precision Biologic	07/17/2020SE
K181525	INNOVANCE Free PS AgGGP · Traditional	Siemens Healthcare Diagnostics Products GmbH	09/07/2018SE
K133005	Hemosil Von Willebrand Activity AssayGGP · Special	Instrumentation Laboratory CO	03/13/2014SE
K102164	Hemosil Protein S Activity AssayGGP · Traditional	Instrumentation Laboratory CO	03/17/2011SE

More from Instrumentation Laboratory CO

510(k)	Device	Decision
K251440	CRYOcheck Chromogenic Factor VIIIGGP · Traditional	08/25/2025SE
K222831	CRYOcheck Factor VIII Deficient Plasma with VWFGJT · Traditional	09/13/2023SE
K214002	CRYOcheck Chromogenic Factor IXGGP · Traditional	12/23/2022SE
K193556	Cryocheck Hex LAGFO · Traditional	10/23/2020SE
K193204	Cryocheck Chromogenic Factor VIIIGGP · Traditional	07/17/2020SE
K060284	Cryocheck Clot ApcrGGW · Traditional	05/10/2006SE
K043571	Cryocheck Clot SGGP · Traditional	03/18/2005SE
K040987	Cryocheck Clot CGGP · Traditional	06/18/2004SE
K032804	Cryocheck Weak Lupus Positive ControlGGC · Traditional	11/03/2003SE
K023991	Chromocheck Antithrombin 25; Chromocheck Antithrombin 50JBQ · Traditional	04/28/2003SE

Questions and answers

When was CRYOcheck FVIII Inhibitor Kit cleared by the FDA?

CRYOcheck FVIII Inhibitor Kit (K183440) received a 510(k) decision of Substantially Equivalent on March 12, 2019, 90 days after the submission was received.

What is the product code of K183440?

The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.