GGN · Class II · 21 CFR 864.5425

FDA Product Code GGN: Plasma, Coagulation Control

Leading manufacturers include Bio-Rad, Instrumentation Laboratory CO and Helena Laboratories.

99
Total
99
Cleared
127d
Avg days
1977
Since

FDA 510(k) Cleared Plasma, Coagulation Control Devices (Product Code GGN)

99 devices
1–24 of 99
Cleared Jan 04, 2012
HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
K113211
Instrumentation Laboratory CO
Hematology · 65d
Cleared Dec 20, 2010
PT-MULTI-CALIBRATOR, MODEL OPAT07
K093848
Dade Behring, Inc.
Hematology · 369d
Cleared Dec 03, 2010
CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL
K103314
Medtronic, Inc.
Hematology · 23d
Cleared Dec 01, 2010
HEPARIN ASSAY CONTROLS
K103313
Medtronic, Inc.
Hematology · 21d
Cleared Oct 09, 2009
HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)
K090563
Instrumentation Laboratory CO
Hematology · 221d
Cleared Dec 19, 2008
HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED
K082859
Instrumentation Laboratory CO
Hematology · 81d
Cleared Jan 29, 2007
COAGUCHEK XS PT CONTROLS
K063823
Roche Diagnostics Corp.
Hematology · 34d
Cleared Dec 01, 2004
CONTROL PLASMA N, PROC CONTROL PLASMA
K042333
Dade Behring, Inc.
Hematology · 93d
Cleared Oct 21, 2004
CONTROL PLASMA N AND CONTROL PLASMA P
K042209
Dade Behring, Inc.
Hematology · 66d
Cleared Oct 18, 2004
HEPARINASE HR ACT CONTROL, MODEL 550-12
K042175
Medtronic Vascular
Hematology · 68d
Cleared Oct 18, 2004
PURPLE/BLACK HEPARIN ASSAY CONTROL
K042206
Medtronic Vascular
Hematology · 63d
Cleared Feb 27, 2004
LYPHOCHEK HEMOSTASIS CONTROL
K040275
Bio-Rad
Hematology · 22d
Cleared Sep 17, 2003
LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
K032611
Bio-Rad
Hematology · 23d
Cleared Aug 08, 2003
LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3
K032017
Bio-Rad
Hematology · 39d
Cleared Jun 06, 2003
CONTROL PLASMA LMW HEPARIN
K030965
Instrumentation Laboratory CO
Hematology · 71d
Cleared Feb 24, 2003
LIQUICHEK D-DIMER CONTROL, MODEL 356, 357
K030182
Bio-Rad
Hematology · 38d
Cleared May 16, 2002
HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
K021024
Instrumentation Laboratory CO
Hematology · 48d
Cleared May 14, 2002
HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED)
K021022
Instrumentation Laboratory CO
Hematology · 46d
Cleared May 14, 2002
HEMOSIL NORMAL CONTROL (ASSAYED)
K021023
Instrumentation Laboratory CO
Hematology · 46d
Cleared Sep 18, 2001
LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783
K012722
Bio-Rad
Hematology · 34d
Cleared Apr 21, 1999
LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789
K990858
Bio-Rad
Hematology · 37d
Cleared Feb 20, 1997
LYPHOCHEK COAGULATION CONTROL
K964963
Bio-Rad
Hematology · 71d
Cleared Mar 11, 1996
PORCINE FACTOR VIII
K952321
Helena Laboratories
Hematology · 298d
Cleared Sep 14, 1994
SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)
K941860
Helena Laboratories
Hematology · 152d

About Product Code GGN - Regulatory Context