510(k) K102510 ยท LCP Assay, Glycosylated Hemoglobin
DIMENSIONS HB1C KIT, MODEL DF105A
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, May 13, 2011 |
| Received | Aug 27, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102510
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2014 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative de Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.