510(k) K013606 ยท LPS Urinary Homocystine (Nonquantitative) Test System
ACS 180 HOMOCYSTEINE ASSAY
| Applicant | Bayer Diagnostics Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Dec 21, 2001 |
| Received | Oct 31, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013606
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.