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 Jun 21, 2017
VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
K170864
Maine Standards Company, LLC
Hematology · 90d
Cleared Mar 16, 2017
VALIDATE Heparin Calibration Verification/Linearity Test Kit
K163498
Maine Standards Company, LLC
Hematology · 93d
Cleared Feb 23, 2017
George King Coumadin Plasma
K161316
George King Bio-Medical, Inc.
Hematology · 288d
Cleared Jan 05, 2017
VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
K162705
Maine Standards Company, LLC
Hematology · 99d
Cleared Jun 03, 2016
VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
K152961
Maine Standards Company, LLC
Hematology · 240d
Cleared Mar 06, 2016
VisuCon-F Low Fibrinogen Control Plasma
K150144
Affinity Biologicals, Inc.
Hematology · 409d
Cleared Dec 12, 2014
POOL NORM
K142132
Diagnostics Stago S.A.S.
Hematology · 130d
Cleared Aug 15, 2014
HEMOSIL D-DIMER HS 500 CONTROL
K133582
Instrumentation Laboratory
Hematology · 267d
Cleared Jul 03, 2013
DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
K120977
International Technidyne Corp.
Hematology · 457d
Cleared May 31, 2013
I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
K120900
Cliniqa Corporation
Hematology · 431d
Cleared Mar 14, 2013
STA- COAG CONTROL (N+ABN) PLUS
K120014
Diagnostica Stago, Inc.
Hematology · 441d
Cleared Jan 04, 2012
HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
K113211
Instrumentation Laboratory CO
Hematology · 65d
Cleared Oct 20, 2011
VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN
K110432
Affinity Biologicals, Inc.
Hematology · 247d
Cleared Jun 23, 2011
AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
K100716
Aalto Scientific, Ltd.
Hematology · 468d
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 Mar 01, 2007
TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
K062840
Biosite Incorporated
Hematology · 160d
Cleared Jan 29, 2007
COAGUCHEK XS PT CONTROLS
K063823
Roche Diagnostics Corp.
Hematology · 34d
Cleared Jan 04, 2006
HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL
K052697
Akers Biosciences, Inc.
Hematology · 98d
Cleared Dec 23, 2005
BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR
K051472
Hyphen Biomed
Hematology · 203d
Cleared Jun 29, 2005
TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS
K050799
Biosite Incorporated
Hematology · 91d

About Product Code GGN - Regulatory Context