GGN · Plasma, Coagulation Control
Hematology · 21 CFR 864.5425 · Class 2
Overview
| Product Code | GGN |
|---|---|
| Device Name | Plasma, Coagulation Control |
| Regulation | 21 CFR 864.5425 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
Classification Rationale
Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (20 of 99)
Showing 20 most recent of 99 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K170864 | VALIDATE D-Dimer Calibration Verification / Linearity Test Kit | Maine Standards Company, LLC | Jun 21, 2017 | SESE |
| K163498 | VALIDATE Heparin Calibration Verification/Linearity Test Kit | Maine Standards Company, LLC | Mar 16, 2017 | SESE |
| K161316 | George King Coumadin Plasma | George King Bio-Medical, Inc. | Feb 23, 2017 | SESE |
| K162705 | VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC | Jan 5, 2017 | SESE |
| K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test Kit | Maine Standards Company, LLC | Jun 3, 2016 | SESE |
| K150144 | VisuCon-F Low Fibrinogen Control Plasma | Affinity Biologicals, Inc. | Mar 6, 2016 | SESE |
| K142132 | POOL NORM | Diagnostics Stago S.A.S. | Dec 12, 2014 | SESE |
| K133582 | HEMOSIL D-DIMER HS 500 CONTROL | Instrumentation Laboratory | Aug 15, 2014 | SESE |
| K120977 | DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC | International Technidyne Corp. | Jul 3, 2013 | SESE |
| K120900 | I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 | Cliniqa Corporation | May 31, 2013 | SESE |
| K120014 | STA- COAG CONTROL (N+ABN) PLUS | Diagnostica Stago, Inc. | Mar 14, 2013 | SESE |
| K113211 | HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL | Instrumentation Laboratory CO | Jan 4, 2012 | SESE |
| K110432 | VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN | Affinity Biologicals, Inc. | Oct 20, 2011 | SESE |
| K100716 | AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 | Aalto Scientific, Ltd. | Jun 23, 2011 | SESE |
| K093848 | PT-MULTI-CALIBRATOR, MODEL OPAT07 | Dade Behring, Inc. | Dec 20, 2010 | SESE |
| K103314 | CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL | Medtronic, Inc. | Dec 3, 2010 | SESE |
| K103313 | HEPARIN ASSAY CONTROLS | Medtronic, Inc. | Dec 1, 2010 | SESE |
| K091284 | VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA | Affinity Biologicals, Inc. | Oct 28, 2009 | SESE |
| K090563 | HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) | Instrumentation Laboratory CO | Oct 9, 2009 | SESE |
| K082859 | HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED | Instrumentation Laboratory CO | Dec 19, 2008 | SESE |
Top Applicants
- Bio-Rad — 7 clearances
- Helena Laboratories — 7 clearances
- Instrumentation Laboratory CO — 7 clearances
- Precision Biologicals, Inc. — 6 clearances
- American Bioproducts Co. — 5 clearances
