GGN — Plasma, Coagulation Control Class II
FDA Device Classification
Classification Details
- Product Code
- GGN
- Device Class
- Class II
- Regulation Number
- 864.5425
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K170864 | maine standards company | VALIDATE D-Dimer Calibration Verification / Linearity Test Kit | June 21, 2017 |
| K163498 | maine standards company | VALIDATE Heparin Calibration Verification/Linearity Test Kit | March 16, 2017 |
| K161316 | george king bio-medical | George King Coumadin Plasma | February 23, 2017 |
| K162705 | maine standards company | VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit | January 5, 2017 |
| K152961 | maine standards company | VALIDATE D-Dimer Calibration Verification/Linearity Test Kit | June 3, 2016 |
| K150144 | affinity biologicals | VisuCon-F Low Fibrinogen Control Plasma | March 6, 2016 |
| K142132 | diagnostics stago | POOL NORM | December 12, 2014 |
| K133582 | instrumentation laboratory | HEMOSIL D-DIMER HS 500 CONTROL | August 15, 2014 |
| K120977 | international technidyne | DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DI | July 3, 2013 |
| K120900 | cliniqa corporation | I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 | May 31, 2013 |
| K120014 | diagnostica stago | STA- COAG CONTROL (N+ABN) PLUS | March 14, 2013 |
| K113211 | instrumentation laboratory | HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL | January 4, 2012 |
| K110432 | affinity biologicals | VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN | October 20, 2011 |
| K100716 | aalto scientific | AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 | June 23, 2011 |
| K093848 | dade behring | PT-MULTI-CALIBRATOR, MODEL OPAT07 | December 20, 2010 |
| K103314 | medtronic | CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL | December 3, 2010 |
| K103313 | medtronic | HEPARIN ASSAY CONTROLS | December 1, 2010 |
| K091284 | affinity biologicals | VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONT | October 28, 2009 |
| K090563 | instrumentation laboratory | HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) | October 9, 2009 |
| K082859 | instrumentation laboratory | HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED | December 19, 2008 |