GGN · Class II · 21 CFR 864.5425

FDA Product Code GGN: Plasma, Coagulation Control

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

99
Total
99
Cleared
127d
Avg days
1977
Since
99 devices
25–48 of 99
Cleared Mar 17, 2005
BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA
K043451
Hyphen Biomed
Hematology · 93d
Cleared Dec 22, 2004
PEFAKIT APC-R FACTOR V LEIDEN CONTROLS
K042760
Pentapharm , Ltd.
Hematology · 78d
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 Sep 07, 2001
PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560
K010750
Fisher Diagnostics
Hematology · 178d
Cleared Apr 09, 2001
STA-QUALITY HBPM/LMWH KIT
K010324
Diagnostica Stago, Inc.
Hematology · 66d
Cleared Apr 09, 2001
STA -CALIBRATOR HBPM/LMWH KIT
K010350
Diagnostica Stago, Inc.
Hematology · 63d
Cleared Mar 24, 2000
THROMBOSTRATE CONTROL PLASMAS
K000679
Pacific Hemostasis
Hematology · 24d
Cleared Feb 15, 2000
HMP CONTROLS (TAS) RAPIDPOINT
K994159
Cardiovascular Diagnostics, Inc.
Hematology · 68d
Cleared Dec 20, 1999
POLLER CALIBRANTS
K991439
European Concerted Action on Anticoagulation
Hematology · 238d
Cleared Nov 22, 1999
CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
K992829
Medical Analysis Systems, Inc.
Hematology · 91d
Cleared Aug 26, 1999
HEPARIN CONTROL PLASMA LEVEL 1
K992278
Pacific Hemostasis
Hematology · 50d
Cleared Aug 26, 1999
HEPARIN CONTROL PLASMA LEVEL 2
K992279
Pacific Hemostasis
Hematology · 50d