Product code GGN
- Device name
- Plasma, Coagulation Control
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.5425
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170864 | VALIDATE D-Dimer Calibration Verification / Linearity Test Kit | Maine Standards Company, LLC | 2017-06-21 |
| K163498 | VALIDATE Heparin Calibration Verification/Linearity Test Kit | Maine Standards Company, LLC | 2017-03-16 |
| K161316 | George King Coumadin Plasma | George King Bio-Medical, Inc. | 2017-02-23 |
| K162705 | VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC | 2017-01-05 |
| K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test Kit | Maine Standards Company, LLC | 2016-06-03 |
| K150144 | VisuCon-F Low Fibrinogen Control Plasma | Affinity Biologicals, Inc. | 2016-03-06 |
| K142132 | POOL NORM | Diagnostics Stago S.A.S. | 2014-12-12 |
| K133582 | HEMOSIL D-DIMER HS 500 CONTROL | Instrumentation Laboratory | 2014-08-15 |
| K120977 | DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC | International Technidyne Corp. | 2013-07-03 |
| K120900 | I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 | Cliniqa Corporation | 2013-05-31 |
| K120014 | STA- COAG CONTROL (N+ABN) PLUS | Diagnostica Stago, Inc. | 2013-03-14 |
| K113211 | HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL | Instrumentation Laboratory CO | 2012-01-04 |
| K110432 | VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN | Affinity Biologicals, Inc. | 2011-10-20 |
| K100716 | AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 | Aalto Scientific, Ltd. | 2011-06-23 |
| K093848 | PT-MULTI-CALIBRATOR, MODEL OPAT07 | Dade Behring, Inc. | 2010-12-20 |
| K103314 | CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL | Medtronic, Inc. | 2010-12-03 |
| K103313 | HEPARIN ASSAY CONTROLS | Medtronic, Inc. | 2010-12-01 |
| K091284 | VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA | Affinity Biologicals, Inc. | 2009-10-28 |
| K090563 | HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) | Instrumentation Laboratory CO | 2009-10-09 |
| K082859 | HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED | Instrumentation Laboratory CO | 2008-12-19 |
| K071319 | I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 | Bio-Rad, Diagnostics Grp. | 2007-06-26 |
| K062840 | TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS | Biosite Incorporated | 2007-03-01 |
| K063823 | COAGUCHEK XS PT CONTROLS | Roche Diagnostics Corp. | 2007-01-29 |
| K052697 | HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL | Akers Biosciences, Inc. | 2006-01-04 |
| K051472 | BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR | Hyphen Biomed | 2005-12-23 |
| K050799 | TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS | Biosite Incorporated | 2005-06-29 |
| K043451 | BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR | Hyphen Biomed | 2005-03-17 |
| K042760 | PEFAKIT APC-R FACTOR V LEIDEN CONTROLS | Pentapharm , Ltd. | 2004-12-22 |
| K042333 | CONTROL PLASMA N, PROC CONTROL PLASMA | Dade Behring, Inc. | 2004-12-01 |
| K042209 | CONTROL PLASMA N AND CONTROL PLASMA P | Dade Behring, Inc. | 2004-10-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08426951011131 | HemosIL CL Multi-Ab Controls | INSTRUMENTATION LABORATORY COMPANY | 2025-10-30 |
| 08718734962724 | CueSee® Coag | Eurotrol B.V. | 2025-04-08 |
| 08718734962731 | CueSee® Coag | Eurotrol B.V. | 2025-04-08 |
| 08718734962748 | CueSee® Coag | Eurotrol B.V. | 2025-04-08 |
| 08718734962755 | CueSee® Coag | Eurotrol B.V. | 2025-04-08 |
| 08718734962762 | CueSee® Coag | Eurotrol B.V. | 2025-04-08 |
| 10711234170373 | directCHECK ACT-LR Whole Blood Control, Level 2 | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | 2022-01-21 |
| 10711234170366 | directCHECK ACT-LR Whole Blood Controls, Level 1 | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | 2022-01-21 |
| 10711234170359 | directCHECK ACT+ Whole Blood Control, Level 2 | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | 2022-01-21 |
| 10711234170342 | directCHECK ACT+ Whole Blood Control Level 1 | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | 2022-01-21 |
| 20763000014807 | N/A | MEDTRONIC, INC. | 2021-11-12 |
| 20812747018491 | Haemonetics TEG 6s | HAEMONETICS CORPORATION | 2021-06-17 |
| 10629009051058 | VisuCon-F Frozen Calibrator Plasma | Affinity Biologicals Inc | 2017-04-28 |
| 10629009031050 | VisuCon-F Low Fibrinogen Control Plasma | Affinity Biologicals Inc | 2017-04-28 |
| 10629009031258 | VisuCon-F Low Fibrinogen Control Plasma | Affinity Biologicals Inc | 2017-04-28 |
| 10629009031814 | VisuCon-F Low Fibrinogen Control Plasma | Affinity Biologicals Inc | 2017-04-28 |
| 10629009061255 | VisuCon-F Frozen Abnormal Control Plasma | Affinity Biologicals Inc | 2017-04-28 |
| 10629009051256 | VisuCon-F Frozen Normal Control Plasma | Affinity Biologicals Inc | 2017-04-28 |
| 10629009061057 | VisuCon-F Frozen Abnormal Control Plasma | Affinity Biologicals Inc | 2017-04-28 |
| 10629009084810 | VisuCon-F Frozen Coag Screen ABN | Affinity Biologicals Inc | 2017-04-28 |
| 10629009081819 | VisuCon-F Frozen Coag Screen ABN | Affinity Biologicals Inc | 2017-04-28 |
| 10629009081253 | VisuCon-F Frozen Coag Screen ABN | Affinity Biologicals Inc | 2017-04-28 |
| 10629009074811 | VisuCon-F Frozen Coag Screen N | Affinity Biologicals Inc | 2017-04-28 |
| 10629009071810 | VisuCon-F Frozen Coag Screen N | Affinity Biologicals Inc | 2017-04-28 |
| 10629009071254 | VisuCon-F Frozen Coag Screen N | Affinity Biologicals Inc | 2017-04-28 |
| 10859394006177 | PlasmaRef ARN | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 10859394006184 | PlasmaRef ARL-2 | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 15391521420708 | TriniCAL™ Reference Plasma | TCOAG IRELAND LIMITED | 2016-09-12 |
| M52551850 | Coagulation S.A.R.P (Specialty Assayed Reference Plasma) | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52551830 | AB-Trol 3 Coagulation Control | HELENA LABORATORIES CORPORATION | 2016-08-18 |