Panels › Hematology › Product code GGN · Class 2
Plasma, Coagulation Control
Regulation 864.5425
0510(k)s in 12 months (99 all time)
2recalls in 12 months (16 all time)
15recalls that name a 510(k)
Top companies in GGN
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 21, 2017 | K170864 | VALIDATE D-Dimer Calibration Verification / Linearity Test Kit Maine Standards Company, LLC | GGN |
| Mar 16, 2017 | K163498 | VALIDATE Heparin Calibration Verification/Linearity Test Kit Maine Standards Company, LLC | GGN |
| Feb 23, 2017 | K161316 | George King Coumadin Plasma George King Bio-Medical, Inc. | GGN |
| Jan 5, 2017 | K162705 | VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit Maine Standards Company, LLC | GGN |
| Jun 3, 2016 | K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test Kit Maine Standards Company, LLC | GGN |
| Mar 6, 2016 | K150144 | VisuCon-F Low Fibrinogen Control Plasma Affinity Biologicals, Inc., CA | GGN |
| Dec 12, 2014 | K142132 | POOL NORM Diagnostics Stago S.A.S., FR | GGN |
| Aug 15, 2014 | K133582 | HEMOSIL D-DIMER HS 500 CONTROL Instrumentation Laboratory | GGN |
| Jul 3, 2013 | K120977 | DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC International Technidyne Corp. | GGN |
| May 31, 2013 | K120900 | I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 Cliniqa Corporation | GGN |
| Mar 14, 2013 | K120014 | STA- COAG CONTROL (N+ABN) PLUS Diagnostica Stago, Inc. | GGN |
| Jan 4, 2012 | K113211 | HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL Instrumentation Laboratory CO | GGN |
| Oct 20, 2011 | K110432 | VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN Affinity Biologicals, Inc., CA | GGN |
| Jun 23, 2011 | K100716 | AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 Aalto Scientific, Ltd. | GGN |
| Dec 20, 2010 | K093848 | PT-MULTI-CALIBRATOR, MODEL OPAT07 Dade Behring, Inc. | GGN |
| Dec 3, 2010 | K103314 | CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL Medtronic, Inc. | GGN |
| Dec 1, 2010 | K103313 | HEPARIN ASSAY CONTROLS Medtronic, Inc. | GGN |
| Oct 28, 2009 | K091284 | VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA Affinity Biologicals, Inc., CA | GGN |
| Oct 9, 2009 | K090563 | HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) Instrumentation Laboratory CO | GGN |
| Dec 19, 2008 | K082859 | HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED Instrumentation Laboratory CO | GGN |
| Jun 26, 2007 | K071319 | I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 Bio-Rad, Diagnostics Grp. | GGN |
| Mar 1, 2007 | K062840 | TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS Biosite Incorporated | GGN |
| Jan 29, 2007 | K063823 | COAGUCHEK XS PT CONTROLS Roche Diagnostics Corp. | GGN |
| Jan 4, 2006 | K052697 | HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL Akers Biosciences, Inc. | GGN |
| Dec 23, 2005 | K051472 | BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR Hyphen Biomed | GGN |
| Jun 29, 2005 | K050799 | TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS Biosite Incorporated | GGN |
| Mar 17, 2005 | K043451 | BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR Hyphen Biomed | GGN |
| Dec 22, 2004 | K042760 | PEFAKIT APC-R FACTOR V LEIDEN CONTROLS Pentapharm , Ltd. | GGN |
| Dec 1, 2004 | K042333 | CONTROL PLASMA N, PROC CONTROL PLASMA Dade Behring, Inc. | GGN |
| Oct 21, 2004 | K042209 | CONTROL PLASMA N AND CONTROL PLASMA P Dade Behring, Inc. | GGN |
| Oct 18, 2004 | K042206 | PURPLE/BLACK HEPARIN ASSAY CONTROL Medtronic Vascular | GGN |
| Oct 18, 2004 | K042175 | HEPARINASE HR ACT CONTROL, MODEL 550-12 Medtronic Vascular | GGN |
| Feb 27, 2004 | K040275 | LYPHOCHEK HEMOSTASIS CONTROL Bio-Rad | GGN |
| Sep 17, 2003 | K032611 | LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743 Bio-Rad | GGN |
| Aug 8, 2003 | K032017 | LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 Bio-Rad | GGN |
| Jun 6, 2003 | K030965 | CONTROL PLASMA LMW HEPARIN Instrumentation Laboratory CO | GGN |
| Feb 24, 2003 | K030182 | LIQUICHEK D-DIMER CONTROL, MODEL 356, 357 Bio-Rad | GGN |
| Jul 23, 2002 | K022046 | VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL Vital Scientific N.V. | GGN |
| May 16, 2002 | K021024 | HEMOSIL HIGH ABNORMAL CONTROL ASSAYED Instrumentation Laboratory CO | GGN |
| May 14, 2002 | K021023 | HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED) Instrumentation Laboratory CO | GGN |
| May 14, 2002 | K021022 | HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) Instrumentation Laboratory CO | GGN |
| Sep 18, 2001 | K012722 | LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783 Bio-Rad | GGN |
| Sep 7, 2001 | K010750 | PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 Fisher Diagnostics | GGN |
| Apr 9, 2001 | K010350 | STA -CALIBRATOR HBPM/LMWH KIT Diagnostica Stago, Inc. | GGN |
| Apr 9, 2001 | K010324 | STA-QUALITY HBPM/LMWH KIT Diagnostica Stago, Inc. | GGN |
| Mar 24, 2000 | K000679 | THROMBOSTRATE CONTROL PLASMAS Pacific Hemostasis | GGN |
| Feb 15, 2000 | K994159 | HMP CONTROLS (TAS) RAPIDPOINT Cardiovascular Diagnostics, Inc. | GGN |
| Dec 20, 1999 | K991439 | POLLER CALIBRANTS European Concerted Action on Anticoagulation, GB | GGN |
| Nov 22, 1999 | K992829 | CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3 Medical Analysis Systems, Inc. | GGN |
| Aug 26, 1999 | K992279 | HEPARIN CONTROL PLASMA LEVEL 2 Pacific Hemostasis | GGN |
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