GGNClass II

Plasma, Coagulation Control

21 CFR 864.5425 / Hematology

GGN is the FDA product code for Plasma, Coagulation Control, a class II device type, regulated under 21 CFR 864.5425. As of 2026-09-10, FDA records hold 99 510(k) clearances under this code, the most recent dated 2017-06-21, and 16 recalls.

Classification record

Product code: GGN
Device name: Plasma, Coagulation Control
Regulation: 21 CFR 864.5425
Device class: Class II
Review panel: Hematology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 99
Ingested recalls: 16

Clearances, product code GGN

By decision year

99 clearances under product code GGN with a decision year between 1977 and 2017, 1995 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code GGN by decision year
Year	Clearances
1977	1
1984	2
1988	4
1989	2
1990	5
1991	2
1992	4
1993	1
1994	2
1995	6
1996	6
1997	6
1998	6
1999	5
2000	2
2001	4
2002	4
2003	4
2004	6
2005	3
2006	1
2007	3
2008	1
2009	2
2010	3
2011	2
2012	1
2013	3
2014	2
2016	2
2017	4

Applicants with the most clearances

Product code GGN

Applicants holding the most 510(k) clearances under product code GGN
Applicant	Clearances
Instrumentation Laboratory Co.	8
Bio-Rad	7
Helena Laboratories, Corp.	7
Precision Biologicals, Inc.	6
American Bioproducts Co.	5
Cardiovascular Diagnostics, Inc.	5
Pacific Hemostasis	5
Accriva Diagnostics, Inc.	4
Maine Standards Co.	4
Medtronic, Inc.	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 39 companies shown, in name order