510(k) K072732 ยท MIU Enzyme Linked Immunosorbent Assay, T. Cruzi
ORTHO T. CRUZI ELISA TEST SYSTEM
| Applicant | Ortho-Clinical Diagnostics, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Apr 15, 2009 |
| Received | Sep 26, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072732
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.