Factor Deficient Plasma

Q: What is the product code of K961929?

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) K961929 · Universal Reagents, Inc.

Substantially Equivalent

510(k) numberK961929

Submission

Device name: Factor Deficient Plasma
Applicant: Universal Reagents, Inc.
Indianapolis, IN, US
Received: May 17, 1996
Decision date: October 10, 1996
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

510(k)	Device	Decision
K973143	Universal Reagent Factor Xii (Twelve) Deficient PlasmaGGP · Traditional	09/25/1997SE
K972288	Factor Deficient Plasmas - Factor Ix (9)GGP · Traditional	07/14/1997SE
K972286	Factor Deficient Plasmas - Factor Xi (11)GJT · Traditional	07/14/1997SE
K970607	Universal Reagent Factor Vii Deficient PlasmaGJT · Traditional	04/25/1997SE
K970593	Universal Reagent Factor Viii Deficient PlasmaGJT · Traditional	04/25/1997SE
K964459	Universal Reagent Factor X Deficient PlasmaGGP · Traditional	12/18/1996SE
K964270	Universal Reagent Factor V Deficient PlasmaGGP · Traditional	12/18/1996SE

Questions and answers

When was Factor Deficient Plasma cleared by the FDA?

Factor Deficient Plasma (K961929) received a 510(k) decision of Substantially Equivalent on October 10, 1996, 146 days after the submission was received.

What is the product code of K961929?

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