Human Protein C Rid Test Kit

Q: What is the product code of K950015?

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) K950015 · Jay H. Geller

Substantially Equivalent

510(k) numberK950015

Submission

Device name: Human Protein C Rid Test Kit
Applicant: Jay H. Geller
Santa Monica, CA, US
Received: January 3, 1995
Decision date: March 6, 1995
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
K971658	Mouse Liver Kidney Stomach Diagnostic Test KitDBL · Traditional	05/23/1997SE
K942326	Human C5 Rid KitsDAY · Traditional	08/24/1995SE
K943334	Hawley Retainer Orthodontic Applicance KitDZC · Traditional	10/05/1994SE

Questions and answers

When was Human Protein C Rid Test Kit cleared by the FDA?

Human Protein C Rid Test Kit (K950015) received a 510(k) decision of Substantially Equivalent on March 6, 1995, 62 days after the submission was received.

What is the product code of K950015?

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