510(k) K110212 ยท GJS Test, Time, Prothrombin
INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP
| Applicant | Alere San Diego, Inc (Formally Biosite Incorporate, San Diego CA, US |
| Decision | Unknown, May 1, 2012 |
| Received | Jan 25, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110212
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2016 | Alere San Diego, Inc. Alere INRatio PT/INR System Professional
Model Numbers: 0100004
Product Usage:
Alere INRatio 2 PT/INR Monitoring System (Professional Use): The Alere INRatio 2 PT/INR Monitoring System (Professiona Terminated |
GJS | None listed |
| Aug 19, 2016 | Alere San Diego, Inc. Alere INRatio2 PT/INR Home Monitoring System
Model Number: 0200432, 0200433
Product Usage:
Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting Terminated |
GJS | None listed |
| Aug 19, 2016 | Alere San Diego, Inc. Alere INRatio2 Replacement Monitor (Home)
Model Number: 0200457
Product Usage:
Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRa 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.