510(k) K021535 ยท JIT Calibrator, Secondary
ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR
| Applicant | Bayer Diagnostics Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jun 27, 2002 |
| Received | May 10, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021535
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2017 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899 Terminated |
JIT | None listed |
| Apr 19, 2017 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of insulin in serum. Terminated |
CFP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.