GGN — Plasma, Coagulation Control Class II
FDA product code GGN covers "Plasma, Coagulation Control", a Class II medical device regulated under 21 CFR 864.5425. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |