GGP · Class II · 21 CFR 864.7290

FDA Product Code GGP: Test, Qualitative And Quantitative Factor Deficiency

Leading manufacturers include Instrumentation Laboratory CO, Helena Laboratories and Sigma Chemical Co..

190
Total
190
Cleared
108d
Avg days
1977
Since
Declining activity - 1 submissions in the last 2 years vs 4 in the prior period
Consistent review times: 108d avg (recent)

FDA 510(k) Cleared Test, Qualitative And Quantitative Factor Deficiency Devices (Product Code GGP)

190 devices
1–24 of 190
Cleared Aug 25, 2025
CRYOcheck Chromogenic Factor VIII
K251440
Precision Biologic, Inc.
Hematology · 108d
Cleared Dec 13, 2023
HemosIL Chromogenic Factor IX
K230852
Instrumentation Laboratory Company
Hematology · 260d
Cleared Jun 02, 2023
vWF Ag
K220728
Siemens Healthcare Diagnostics Products GmbH
Hematology · 445d
Cleared Dec 23, 2022
CRYOcheck Chromogenic Factor IX
K214002
Precision Biologic, Inc.
Hematology · 367d
Cleared Dec 09, 2022
HemosIL von Willebrand Factor Antigen
K223402
Instrumentation Laboratory CO
Hematology · 30d
Cleared Aug 19, 2020
HemosIL von Willebrand Factor Antigen
K200033
Instrumentation Laboratory CO
Hematology · 225d
Cleared Jul 17, 2020
Cryocheck Chromogenic Factor VIII
K193204
Precision Biologic
Hematology · 240d
Cleared Mar 12, 2019
CRYOcheck FVIII Inhibitor Kit
K183440
Precision Biologic, Inc.
Hematology · 90d
Cleared Sep 07, 2018
INNOVANCE Free PS Ag
K181525
Siemens Healthcare Diagnostics Products GmbH
Hematology · 88d
Cleared Mar 13, 2014
HEMOSIL VON WILLEBRAND ACTIVITY ASSAY
K133005
Instrumentation Laboratory CO
Hematology · 169d
Cleared Mar 17, 2011
HEMOSIL PROTEIN S ACTIVITY ASSAY
K102164
Instrumentation Laboratory CO
Hematology · 227d
Cleared Mar 29, 2007
HEMOSIL PROCLOT
K070635
Instrumentation Laboratory CO
Hematology · 22d
Cleared Sep 01, 2006
HEMOSIL PROTEIN C
K062430
Instrumentation Laboratory CO
Hematology · 11d
Cleared Jan 13, 2006
HEMOSIL PROS
K053499
Instrumentation Laboratory CO
Hematology · 28d
Cleared Dec 02, 2004
COATEST SP FVIII
K042576
Instrumentation Laboratory CO
Hematology · 71d
Cleared Apr 30, 2004
HEMOSIL VON WILLEBRAND ACTIVITY
K040843
Instrumentation Laboratory CO
Hematology · 29d
Cleared Dec 15, 2003
MODIFICATION TO COATEST FACTOR VIII
K033631
Instrumentation Laboratory CO
Hematology · 26d
Cleared Aug 27, 2002
PROTEIN S AC
K022290
Dade Behring, Inc.
Hematology · 43d
Cleared Jun 25, 2001
IL TEST PROS
K011424
Instrumentation Laboratory CO
Hematology · 47d
Cleared Apr 13, 2001
IL TEST FREE PROTEIN S
K010379
Instrumentation Laboratory CO
Hematology · 64d
Cleared Oct 13, 2000
COALIZA PROTEIN S-FREE
K002467
Instrumentation Laboratory CO
Hematology · 63d
Cleared Sep 26, 2000
PROTEIN C REAGENT
K002541
Dade Behring, Inc.
Hematology · 41d
Cleared Apr 25, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K000649
Dade Behring, Inc.
Hematology · 57d
Cleared Nov 01, 1999
IL TEST VON WILLEBRAND FACTOR
K992704
Instrumentation Laboratory CO
Hematology · 81d

About Product Code GGP - Regulatory Context

510(k) Submission Activity

190 total 510(k) submissions under product code GGP since 1977, with 190 receiving FDA clearance (average review time: 108 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - GGP Product Code

FDA review times for GGP submissions have been consistent, averaging 108 days recently vs 108 days historically.

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