510(k) K101460 ยท JIX Calibrator, Multi-Analyte Mixture
LOCI 8 CALIBRATOR, MODEL KC 646
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Jul 9, 2010 |
| Received | May 26, 2010 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K101460
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista System LOCI 8 CALIBRATOR
The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.