Coaliza Protein S-Free

Q: What is the product code of K002467?

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) K002467 · Instrumentation Laboratory CO

Substantially Equivalent

510(k) numberK002467

Submission

Device name: Coaliza Protein S-Free
Applicant: Instrumentation Laboratory CO
Bedford, MA, US
Received: August 11, 2000
Decision date: October 13, 2000
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

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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
K183440	CRYOcheck FVIII Inhibitor KitGGP · Traditional	Precision Biologic, Inc.	03/12/2019SE
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

More from Instrumentation Laboratory CO

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K230852	HemosIL Chromogenic Factor IXGGP · Traditional	12/13/2023SE
K221359	ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional	09/29/2023SE
K223608	GEM Premier 7000 with IQM3CHL · Traditional	08/10/2023SE
K223187	HemosIL Liquid Anti-XaQLU · Traditional	06/23/2023SE
K231031	ACL TOP Family 70 SeriesGKP · Traditional	06/21/2023SE
K223090	GEM Premier ChemSTATCGA · Special	01/27/2023SE
K223402	HemosIL von Willebrand Factor AntigenGGP · Special	12/09/2022SE
K213464	HemosIL Liquid Anti-XaKFF · Special	10/04/2022SE
K213426	HemosIL ReadiPlasTinGJS · Traditional	08/16/2022SE

Questions and answers

When was Coaliza Protein S-Free cleared by the FDA?

Coaliza Protein S-Free (K002467) received a 510(k) decision of Substantially Equivalent on October 13, 2000, 63 days after the submission was received.

What is the product code of K002467?

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