510(k) K071466 ยท LCP Assay, Glycosylated Hemoglobin
DCA VANTAGE, MODEL 5075
| Applicant | Siemens Medical Solutions Diagnostics, Norowood MA, US |
| Decision | Substantially Equivalent, Oct 9, 2007 |
| Received | May 29, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071466
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2020 | Siemens Healthcare Diagnostics, Inc. DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 -
HC0015BZZWW external accessory to DCA Vantage Analyzer US Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.