510(k) K061598 ยท LPS Urinary Homocystine (Nonquantitative) Test System
HEMOSIL HOMOCYSTEINE AND CONTROLS
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Sep 22, 2006 |
| Received | Jun 8, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061598
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.