510(k) K021923 ยท GJS Test, Time, Prothrombin
INRATIO SELF-TEST
| Applicant | Hemosense, Inc., Milpitas CA, US |
| Decision | Substantially Equivalent, Oct 24, 2002 |
| Received | Jun 11, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021923
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 Monitors
- 0100004 Alere INRatio PT/INR System Professional
- 0100007 INRatio Prothrombin Time (PT) Monitoring System
- 0100137 Alere INRatio Replacement Monitor
The test systems contain indi 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 |
| Nov 15, 2005 | HemoSense Inc HemoSense brand INRatio Prothombin Time Monitoring System,
Software Version 1.25.21;
Product is distributed by HemoSense, Inc., 651 River Oaks Pkwy., San Jose, CA 95134 Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.