510(k) K152245 ยท LEH Radioimmunoassay, Vancomycin
ONLINE TDM Vancomycin Gen.3
| Applicant | Roche Diagnostics Operations (Rdo), Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 8, 2016 |
| Received | Aug 10, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152245
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2019 | Roche Diagnostics Operations, Inc. Online TDM Vancomycin Gen.3 (100 tests)
Catalog # 06779336190
Analyzer/Module: cobas c 311 and cobas c 501/502 Terminated |
LEH | None listed |
| Jul 23, 2019 | Roche Diagnostics Operations, Inc. Online TDM Vancomycin Gen.3 ( 200 tests)
Catalog # 06779344190
Analyzer/Module: cobas c 311 and cobas c 501/502 Terminated |
LEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.