510(k) K020355 ยท GJS Test, Time, Prothrombin
I-STAT PROTHROMBIN TIME TEST
| Applicant | I-Stat Corporation, East Windsor NJ, US |
| Decision | Substantially Equivalent, May 14, 2002 |
| Received | Feb 4, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020355
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2015 | Abbott Point Of Care Inc. i-Stat PT/INR Cartridges
List number 03P89-24
The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box.
a prothrombin time test useful in monitoring pati Terminated |
GJS | None listed |
| Dec 4, 2013 | Abbott Point Of Care Inc. Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540
The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as C Terminated |
GJS | None listed |
| Aug 8, 2012 | Abbott Point Of Care Inc. I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA
This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin. Terminated |
GJS | None listed |
| Jul 13, 2010 | Abbott Point of Care Inc. i-STAT PT/INR Cartridge
Abbott Point of Care, Princeton, NJ Terminated |
GJS | None listed |
| Jan 23, 2007 | Abbott Point of Care Inc. i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic.
Ref 04J50-01
24
IVD
Abbott Point of Care Inc.
104 Windsor Center Drive
East Windsor, NJ 08520
Product of Canada Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.