510(k) K092987 ยท GJS Test, Time, Prothrombin
INRATIO/INRATIO2 TEST STRIPS
| Applicant | Biosite Incorporated, San Diego CA, US |
| Decision | Substantially Equivalent, Jun 11, 2010 |
| Received | Sep 28, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092987
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2016 | Alere San Diego, Inc. Alere INRatio PT/INR Test Strips
Model Number: 0100071, 0100139
Product Usage:
The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombinant Terminated |
GJS | None listed |
| Aug 19, 2016 | Alere San Diego, Inc. Alere INRatio/ INRatio2 PT/INR Test Strips
Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7
Product Usage:
The Alere INRatio/INRatio2 system uses 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 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 |
| 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 |
| May 8, 2014 | Alere San Diego, Inc. Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the Monitor and test strip, is used for quantitativ Terminated |
GJS | None listed |
| Jun 24, 2011 | Alere San Diego 0200086, Triad Alcohol Prep Pads, 100 box
0200432, Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or
Hemosense INRatio 2 Prothrombin Time/lNR Testing Kit, Self-Test Sys Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.