FDA 510(k) Applications for Medical Device Product Code "GGN"
(Plasma, Coagulation Control)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K100716 | AALTO SCIENTIFIC LTD. | AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 | 06/23/2011 |
| K091284 | AFFINITY BIOLOGICALS INC. | VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA | 10/28/2009 |
| K110432 | AFFINITY BIOLOGICALS INC. | VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN | 10/20/2011 |
| K150144 | AFFINITY BIOLOGICALS INC. | VisuCon-F Low Fibrinogen Control Plasma | 03/06/2016 |
| K052697 | Akers Biosciences, Inc. | HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL | 01/04/2006 |
| K962674 | AMERICAN BIOPRODUCTS CO. | STA - VWF CONTROL [N]+[P] KIT | 07/23/1996 |
| K964716 | AMERICAN BIOPRODUCTS CO. | STA LIATEST CONTROL [N]+[P] KIT | 06/26/1997 |
| K980982 | AVOCET MEDICAL, INC. | AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2 | 04/16/1998 |
| K955278 | BEHRING DIAGNOSTICS, INC. | BEHRING COAGULATION TIMER | 05/30/1996 |
| K032017 | BIO-RAD | LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 | 08/08/2003 |
| K030182 | BIO-RAD | LIQUICHEK D-DIMER CONTROL, MODEL 356, 357 | 02/24/2003 |
| K964963 | BIO-RAD | LYPHOCHEK COAGULATION CONTROL | 02/20/1997 |
| K012722 | BIO-RAD | LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783 | 09/18/2001 |
| K032611 | BIO-RAD | LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743 | 09/17/2003 |
| K040275 | BIO-RAD | LYPHOCHEK HEMOSTASIS CONTROL | 02/27/2004 |
| K990858 | BIO-RAD | LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 | 04/21/1999 |
| K071319 | BIO-RAD, DIAGNOSTICS GRP. | I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 | 06/26/2007 |
| K981752 | BIOPOOL INTL., INC. | I-STAT COAGULATION CONTROL SET | 06/15/1998 |
| K062840 | BIOSITE INCORPORATED | TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS | 03/01/2007 |
| K050799 | BIOSITE INCORPORATED | TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS | 06/29/2005 |
| K994159 | CARDIOVASCULAR DIAGNOSTICS, INC. | HMP CONTROLS (TAS) RAPIDPOINT | 02/15/2000 |
| K961189 | CARDIOVASCULAR DIAGNOSTICS, INC. | TAS A PTT TEST CONTROLS | 06/05/1996 |
| K960234 | CARDIOVASCULAR DIAGNOSTICS, INC. | TAS HMT CONTROLS | 05/30/1996 |
| K971748 | CARDIOVASCULAR DIAGNOSTICS, INC. | TAS PT-NCTEST CONTROLS | 05/29/1997 |
| K981178 | CARDIOVASCULAR DIAGNOSTICS, INC. | THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS | 04/27/1998 |
| K120900 | CLINIQA CORPORATION | I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 | 05/31/2013 |
| K042209 | DADE BEHRING, INC. | CONTROL PLASMA N AND CONTROL PLASMA P | 10/21/2004 |
| K042333 | DADE BEHRING, INC. | CONTROL PLASMA N, PROC CONTROL PLASMA | 12/01/2004 |
| K093848 | DADE BEHRING, INC. | PT-MULTI-CALIBRATOR, MODEL OPAT07 | 12/20/2010 |
| K010350 | DIAGNOSTICA STAGO, INC. | STA -CALIBRATOR HBPM/LMWH KIT | 04/09/2001 |
| K120014 | DIAGNOSTICA STAGO, INC. | STA- COAG CONTROL (N+ABN) PLUS | 03/14/2013 |
| K010324 | DIAGNOSTICA STAGO, INC. | STA-QUALITY HBPM/LMWH KIT | 04/09/2001 |
| K142132 | Diagnostics Stago S.A.S. | POOL NORM | 12/12/2014 |
| K991439 | EUROPEAN CONCERTED ACTION ON ANTICOAGULATION | POLLER CALIBRANTS | 12/20/1999 |
| K010750 | FISHER DIAGNOSTICS | PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 | 09/07/2001 |
| K161316 | GEORGE KING BIO-MEDICAL, INC. | George King Coumadin Plasma | 02/23/2017 |
| K952321 | HELENA LABORATORIES | PORCINE FACTOR VIII;C REAGENT | 03/11/1996 |
| K051472 | HYPHEN BIOMED | BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR | 12/23/2005 |
| K043451 | HYPHEN BIOMED | BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR | 03/17/2005 |
| K133582 | INSTRUMENTATION LABORATORY | HEMOSIL D-DIMER HS 500 CONTROL | 08/15/2014 |
| K030965 | INSTRUMENTATION LABORATORY CO. | CONTROL PLASMA LMW HEPARIN | 06/06/2003 |
| K021024 | INSTRUMENTATION LABORATORY CO. | HEMOSIL HIGH ABNORMAL CONTROL ASSAYED | 05/16/2002 |
| K090563 | INSTRUMENTATION LABORATORY CO. | HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) | 10/09/2009 |
| K113211 | INSTRUMENTATION LABORATORY CO. | HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL | 01/04/2012 |
| K021022 | INSTRUMENTATION LABORATORY CO. | HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) | 05/14/2002 |
| K021023 | INSTRUMENTATION LABORATORY CO. | HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED) | 05/14/2002 |
| K082859 | INSTRUMENTATION LABORATORY CO. | HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED | 12/19/2008 |
| K120977 | INTERNATIONAL TECHNIDYNE CORP. | DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC | 07/03/2013 |
| K170864 | Maine Standards Company LLC | VALIDATE D-Dimer Calibration Verification / Linearity Test Kit | 06/21/2017 |
| K152961 | MAINE STANDARDS COMPANY LLC | VALIDATE D-Dimer Calibration Verification/Linearity Test Kit | 06/03/2016 |
| K162705 | MAINE STANDARDS COMPANY LLC | VALIDATE« D-Dimer Calibration Verification/ Linearity Test Kit | 01/05/2017 |
| K163498 | MAINE STANDARDS COMPANY, LLC | VALIDATE Heparin Calibration Verification/Linearity Test Kit | 03/16/2017 |
| K992829 | MEDICAL ANALYSIS SYSTEMS, INC. | CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3 | 11/22/1999 |
| K103314 | MEDTRONIC INC. | CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL | 12/03/2010 |
| K103313 | MEDTRONIC INC. | HEPARIN ASSAY CONTROLS | 12/01/2010 |
| K042175 | MEDTRONIC VASCULAR | HEPARINASE HR ACT CONTROL, MODEL 550-12 | 10/18/2004 |
| K042206 | MEDTRONIC VASCULAR | PURPLE/BLACK HEPARIN ASSAY CONTROL | 10/18/2004 |
| K971428 | PACIFIC HEMOSTASIS | COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0 | 06/17/1997 |
| K992278 | PACIFIC HEMOSTASIS | HEPARIN CONTROL PLASMA LEVEL 1 | 08/26/1999 |
| K992279 | PACIFIC HEMOSTASIS | HEPARIN CONTROL PLASMA LEVEL 2 | 08/26/1999 |
| K000679 | PACIFIC HEMOSTASIS | THROMBOSTRATE CONTROL PLASMAS | 03/24/2000 |
| K042760 | PENTAPHARM LTD. | PEFAKIT APC-R FACTOR V LEIDEN CONTROLS | 12/22/2004 |
| K971222 | PRECISION BIOLOGICALS, INC. | CRYO CHECK APC RESISTANT PLASMA | 08/19/1997 |
| K971219 | PRECISION BIOLOGICALS, INC. | CRYO CHECK INR VALIDATION SET | 08/29/1997 |
| K951823 | PRECISION BIOLOGICALS, INC. | CRYO CHECK LOW FIBRINOGEN CONTROL | 01/03/1996 |
| K063823 | ROCHE DIAGNOSTICS CORP. | COAGUCHEK XS PT CONTROLS | 01/29/2007 |
| K981248 | SIGMA DIAGNOSTICS, INC. | SIGMA DIAGNOSTICS ACCUCLOT CONTROL I | 04/29/1998 |
| K981254 | SIGMA DIAGNOSTICS, INC. | SIGMA DIAGNOSTICS ACCUCLOT CONTROL II | 04/29/1998 |
| K981255 | SIGMA DIAGNOSTICS, INC. | SIGMA DIAGNOSTICS ACCUCLOT CONTROL III | 04/29/1998 |
| K022046 | VITAL SCIENTIFIC N.V. | VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL | 07/23/2002 |
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