510(k) K163633 ยท LCP Assay, Glycosylated Hemoglobin
cobas HbA1c Test, cobas b 101 system
| Applicant | Roche Diagnostics Operations, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 28, 2017 |
| Received | Dec 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163633
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.