510(k) K060133 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET
| Applicant | Inverness Medical Innovations, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Feb 16, 2006 |
| Received | Jan 18, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060133
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.