INRATIO 2 PT MONITORING SYSTEM
FDA 510(k) clearance K072727 · decided 2007-10-26
Clearance details
- K-number
- K072727
- Device name
- INRATIO 2 PT MONITORING SYSTEM
- Applicant
- Hemosense, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-26
- Decision date
- 2007-10-26
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- GJS
- Device class
- 2
- Regulation number
- 864.7750
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hemosense
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CoaguChek XS Plus System (K253188) | Roche Diagnostics | 2025-10-24 |
| microINR System (K251564) | Iline Microsystems, S.L. | 2025-07-21 |
| microINR System (K243543) | Iline Microsystems, S.L. | 2025-02-27 |
| Xprecia Prime Coagulation System (K230802) | Universal Biosensors Pty, Ltd. | 2024-03-15 |
| i-STAT PTplus Cartridge with the i-STAT 1 System (K220282) | Abbott Laboratories | 2023-07-14 |
| microINR System (K231711) | Iline Microsystems, S.L. | 2023-07-11 |
| STA- NeoPTimal (K211485) | Diagnostica Stago S.A.S | 2022-12-23 |
| Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (K212779) | Coagusense, Inc. | 2022-10-05 |
| HemosIL ReadiPlasTin (K213426) | Instrumentation Laboratory CO | 2022-08-16 |
| microINR System (K201185) | Iline Microsystems, S.L. | 2020-12-18 |
| Coag-Sense Prothrombin Time (PT) / INR Monitoring Device (K183255) | Coagusense, Inc. | 2019-02-21 |
| microINR System (K180780) | Iline Microsystems, S.L. | 2019-01-25 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The recall (Z-2357-2016) | Alere San Diego, Inc. | 2016-08-19 |
| Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: T recall (Z-2360-2016) | Alere San Diego, Inc. | 2016-08-19 |
| Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere recall (Z-0880-2015) | Alere San Diego, Inc. | 2015-01-03 |
| INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 recall (Z-0882-2015) | Alere San Diego, Inc. | 2015-01-03 |
| PDI Alcohol Prep Pads packaged in the INRatio kit. PDI Alcohol Prep Pads, 100/box. Alcohol recall (Z-0188-2012) | Alere San Diego | 2011-11-16 |
| HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense Incorporated. The I recall (Z-1256-2009) | HemoSense Inc | 2009-05-22 |