Company ยท US
Hemosense, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2007. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GJS | Test, Time, Prothrombin | 5 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2009 | HemoSense Inc 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, capi Terminated |
GJS | K072727 |
| Nov 15, 2005 | HemoSense Inc 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 Terminated |
GJS | K020679 K021923 |