GFOClass II

Activated Partial Thromboplastin

21 CFR 864.7925 / Hematology

GFO is the FDA product code for Activated Partial Thromboplastin, a class II device type, regulated under 21 CFR 864.7925. As of 2026-09-10, FDA records hold 52 510(k) clearances under this code, the most recent dated 2026-01-09, and 10 recalls.

Classification record

Product code: GFO
Device name: Activated Partial Thromboplastin
Regulation: 21 CFR 864.7925
Device class: Class II
Review panel: Hematology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 52
Ingested recalls: 10

Clearances, product code GFO

By decision year

52 clearances under product code GFO with a decision year between 1976 and 2026, 1989 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code GFO by decision year
Year	Clearances
1976	1
1977	1
1978	1
1982	1
1988	3
1989	10
1990	3
1991	3
1992	6
1993	5
1994	1
1995	1
1996	2
1997	3
1999	2
2002	3
2005	1
2006	2
2016	1
2020	1
2026	1

Applicants with the most clearances

Product code GFO

Applicants holding the most 510(k) clearances under product code GFO
Applicant	Clearances
Analytical Control Systems	5
Accriva Diagnostics, Inc.	5
Instrumentation Laboratory Co.	4
Medical Diagnostic Technologies, Inc.	3
Behring Diagnostics, Inc.	2
Elite Diagnostic, Ltd.	2
Helena Laboratories, Corp.	2
Hyland Therapeutic Div., Travenol Laboratories	2
Ortho Diagnostic Systems, Inc.	2
Sigma Chemical Co.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order