GGCClass II

Control, Plasma, Abnormal

21 CFR 864.5425 / Hematology

GGC is the FDA product code for Control, Plasma, Abnormal, a class II device type, regulated under 21 CFR 864.5425. As of 2026-09-10, FDA records hold 40 510(k) clearances under this code, the most recent dated 2011-04-05, and no recalls.

Classification record

Product code: GGC
Device name: Control, Plasma, Abnormal
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: 40
Ingested recalls: 0

Clearances, product code GGC

By decision year

40 clearances under product code GGC with a decision year between 1977 and 2011, 1989 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code GGC by decision year
Year	Clearances
1977	1
1987	1
1988	1
1989	6
1990	3
1991	1
1992	2
1993	2
1994	4
1995	4
1996	2
1998	2
2000	1
2001	2
2002	3
2003	1
2006	1
2007	1
2010	1
2011	1

Applicants with the most clearances

Product code GGC

Applicants holding the most 510(k) clearances under product code GGC
Applicant	Clearances
American Bioproducts Co.	5
Analytical Control Systems	4
Medical Diagnostic Technologies, Inc.	4
Behring Diagnostics, Inc.	3
Helena Laboratories, Corp.	2
Pacific Hemostasis	2
Precision Biologicals, Inc.	2
Sigma Diagnostics, Inc.	2
Baxter Healthcare Corporation	1
Bio-Rad	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order