GFO · Class II · 21 CFR 864.7925

FDA Product Code GFO: Activated Partial Thromboplastin

Leading manufacturers include Analytical Control Systems, Inc., International Technidyne Corp. and Instrumentation Laboratory CO.

52
Total
52
Cleared
100d
Avg days
1976
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 30d recently vs 101d historically

FDA 510(k) Cleared Activated Partial Thromboplastin Devices (Product Code GFO)

52 devices
1–24 of 52
Cleared Jan 09, 2026
HemosIL Silica Clotting Time
K253957
Instrumentation Laboratory (IL) Co.
Hematology · 30d
Cleared Oct 23, 2020
Cryocheck Hex LA
K193556
Precision Biologic
Hematology · 305d
Cleared Mar 16, 2016
HemosIL Silica Clotting Time
K160445
Instrumentation Laboratory CO
Hematology · 28d
Cleared Apr 13, 2006
HEMOSIL SYNTHASIL
K060688
Instrumentation Laboratory CO
Hematology · 29d
Cleared Mar 30, 2005
HEMOSIL SILICA CLOTTING TIME
K050221
Instrumentation Laboratory CO
Hematology · 58d
Cleared Dec 06, 1999
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
K992711
Sigma Diagnostics, Inc.
Hematology · 117d
Cleared Dec 06, 1999
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
K992712
Sigma Diagnostics, Inc.
Hematology · 117d
Cleared Nov 20, 1997
HEMOCHRON CITRATE APTT
K972831
International Technidyne Corp.
Hematology · 113d
Cleared Nov 04, 1997
IL TEST APTT-SP
K973306
Instrumentation Laboratory CO
Hematology · 62d
Cleared Mar 07, 1997
SPECKTIN-LA TEST SET
K961892
Analytical Control Systems, Inc.
Hematology · 295d
Cleared Apr 23, 1996
SYNTHAFAX APTT REAGENT
K955638
Ortho Diagnostic Systems, Inc.
Hematology · 134d
Cleared Apr 19, 1996
PATHROMTIN SL
K955450
Behring Diagnostics, Inc.
Hematology · 142d
Cleared Nov 30, 1995
SYNTHASIL APTT REAGENT
K953981
Ortho Diagnostic Systems, Inc.
Hematology · 99d
Cleared Dec 02, 1994
APTT-ES
K935169
Helena Laboratories
Hematology · 402d
Cleared Dec 06, 1993
APTT-ES REAGENT
K934351
Medical Diagnostic Technologies, Inc.
Hematology · 90d
Cleared Oct 25, 1993
PATHROMTIN
K932011
Behring Diagnostics, Inc.
Hematology · 185d
Cleared Apr 27, 1993
ACS APCT REAGENT, MODIFIED
K926012
Analytical Control Systems, Inc.
Hematology · 158d
Cleared Jan 27, 1993
HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT
K924637
International Technidyne Corp.
Hematology · 148d
Cleared Jan 14, 1993
HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT
K924638
International Technidyne Corp.
Hematology · 135d
Cleared Dec 23, 1992
STACLOT LA TEST KIT
K923731
American Bioproducts Co.
Hematology · 149d
Cleared Oct 19, 1992
PLATELIN L
K921396
Organon Teknika Corp.
Hematology · 210d
Cleared Aug 18, 1992
ACS FREEZE-DRIED APTT REAGENT
K921223
Analytical Control Systems, Inc.
Hematology · 158d
Cleared Jul 28, 1992
ACS APCT REAGENT
K921118
Analytical Control Systems, Inc.
Hematology · 141d
Cleared Feb 14, 1992
ELLAGIC ACID APTT REAGENT
K915418
Helena Laboratories
Hematology · 74d

About Product Code GFO - Regulatory Context

510(k) Submission Activity

52 total 510(k) submissions under product code GFO since 1976, with 52 receiving FDA clearance (average review time: 100 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - GFO Product Code

Recent submissions under GFO have taken an average of 30 days to reach a decision - down from 101 days historically, suggesting improved FDA processing for this classification.

GFO devices are reviewed by the Hematology panel. Browse all Hematology devices →