510(k) K022922 ยท GJS Test, Time, Prothrombin
HARMONY INR MONITORING SYSTEM
| Applicant | Lifescan, Inc., Milpitas CA, US |
| Decision | Substantially Equivalent, Sep 30, 2002 |
| Received | Sep 4, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022922
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.