510(k) K092987— INRATIO/INRATIO2 TEST STRIPS

Substantially Equivalent

Biosite Incorporated

Clearance details

Applicant: Biosite Incorporated
Product code: Code GJS
Advisory panel: Hematology
Date received: 2009-09-28
Decision date: 2010-06-11
Decision: Substantially Equivalent
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, 2020-01-01 through 2026-04-23. 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.