Hemosense, Inc.
Milpitas, CA, US
Hemosense, Inc. appears in FDA device records in Milpitas, CA. FDA records list 3 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Hemosense, Inc. between 2002 and 2007. The busiest year on record is 2002, with 2. The most recent is 2007, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 2 |
| 2007 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1256-2009 | HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense Incorporated. The INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. | INRatio Monitors that were manufactured with a specific EEPROM memory chip fail during use. The monitors report an error code and do not report a test result. | Terminated | ||
| Z-0132-06 | HemoSense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21; Product is distributed by HemoSense, Inc., 651 River Oaks Pkwy., San Jose, CA 95134 | A software problem that may cause the INRatio meter to incorrectly display 'INR>7.5' test message under a particular use condition. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain