510(k) K071587 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY
| Applicant | Inverness Medical Innovations, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Jul 30, 2007 |
| Received | Jun 11, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071587
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.