INRATIO SELF-TEST— 510(k) K021923
Substantially EquivalentHemosense, Inc.
FDA 510(k) clearance K021923 for INRATIO SELF-TEST, Substantially Equivalent on 2002-10-24. Applicant: Hemosense, Inc.. Device class: 2.
Clearance details
- Applicant
- Hemosense, Inc.
- Product code
- Code GJS
- Device class
- Class 2
- Regulation
- 21 CFR 864.7750
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milpitas, CA, US
Recent devices under product code GJS
view allMore clearances from Hemosense, Inc.
view allAdverse 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 →
Recalls naming K021923
K-number listed on FDA's recall record- Z-0880-2015 — 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 are packaged in individually pouched test strips in a labeled box with 12 or 48 test strips per box. In vitro diagnostic system that provides a quantitative prothrombin time result, expressed in seconds and as an International normalized ratio (INR).
- Z-0881-2015 — 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 individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. In vitro diagnostic monitoring system used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021923.
Data sourced from openFDA. This site is unofficial and independent of the FDA.