510(k) K072727 ยท GJS Test, Time, Prothrombin
INRATIO 2 PT MONITORING SYSTEM
| Applicant | Hemosense, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Oct 26, 2007 |
| Received | Sep 26, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072727
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2016 | Alere San Diego, Inc. Alere INRatio2 PT/INR Professional Testing System
Model Number: 0200431
Product Usage:
The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, c Terminated |
GJS | None listed |
| Aug 19, 2016 | Alere San Diego, Inc. Alere INRatio2 PT/INR Professional Monitoring System
Model Number: 55128A
Product Usage:
The Alere INRatio/INRatio2 system uses a modified version of the one-stage PT test. After a drop of blood is a Terminated |
GJS | None listed |
| Jan 3, 2015 | Alere San Diego, Inc. Alere INRatio PT/INR Test Strips, Alere INRatio
PT/INR System Professional
- 0100071 Alere INRatio PT/INR Test Strips, Box of 12
- 0100139 Alere INRatio PT/INR Test Strips, Box of 48
The test strips Terminated |
GJS | None listed |
| Jan 3, 2015 | Alere San Diego, Inc. INRatio 2 Monitors
- 0200431 Alere INRatio 2 PT/INR Professional Testing System
- 0200432 Alere INRatio 2 PT/INR Home Monitoring System
- 0200433 Alere INRatio 2 PT/INR Home Monitoring System
- 020045 Terminated |
GJS | None listed |
| Nov 16, 2011 | Alere San Diego PDI Alcohol Prep Pads packaged in the INRatio kit.
PDI Alcohol Prep Pads, 100/box.
Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or Hemosense INRatio 2 Prothrombin Terminated |
LKB | None listed |
| May 22, 2009 | HemoSense Inc HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense Incorporated.
The INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capi Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.