INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP— 510(k) K110212
UnknownAlere San Diego, Inc (Formally Biosite Incorporate
FDA 510(k) clearance K110212 for INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP, Unknown on 2012-05-01. Applicant: Alere San Diego, Inc (Formally Biosite Incorporate.
Clearance details
- Applicant
- Alere San Diego, Inc (Formally Biosite Incorporate
- Product code
- Code GJS
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Adverse events under product code GJS
product code GJS- Death
- 4
- Injury
- 229
- Malfunction
- 4,852
- Total
- 5,085
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.