Spectrolyse Plasminogen SK Kit

Q: What is the product code of K912025?

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) K912025 · Biopool AB

Substantially Equivalent

510(k) numberK912025

Submission

Device name: Spectrolyse Plasminogen SK Kit
Applicant: Biopool AB
Ontario, L7l 6b8, CA
Received: May 7, 1991
Decision date: August 22, 1991
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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
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

510(k)	Device	Decision
K941752	Spectrolyse Antiplasmin KitGGP · Traditional	09/25/1995SESK
K942087	Biopool VWF Eld Kit and VWF Eld Bulk PlatesGGP · Traditional	07/13/1995SE
K934314	Tintelizer(R) TpaGGP · Traditional	02/23/1994SE
K923499	Spectrolyse Heparin KitKFF · Traditional	01/27/1994SE
K932463	Bioclot laGIR · Traditional	09/27/1993SE
K920668	Minutex D-Dimer Latex TestGHH · Traditional	10/16/1992SE
K922782	Spectrolyse/Pl Pai KitGGP · Traditional	10/09/1992SE
K915163	Protein S Eid Kit and Protein S Eid Bulk PlatesGGP · Traditional	01/06/1992SE
K914307	Spectrolyse Protein C KitGGP · Traditional	12/09/1991SE
K902566	Biopool Protein C Eid Kit and Bulk PlatesGGP · Traditional	08/09/1990SE

Questions and answers

When was Spectrolyse Plasminogen SK Kit cleared by the FDA?

Spectrolyse Plasminogen SK Kit (K912025) received a 510(k) decision of Substantially Equivalent on August 22, 1991, 107 days after the submission was received.

What is the product code of K912025?

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