510(k) K102045 ยท LCP Assay, Glycosylated Hemoglobin
DIMENSION VISA HBA1C, MODEL K3105A
| Applicant | Siemens Heatlhcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Feb 14, 2011 |
| Received | Jul 21, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102045
| 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 |
| Oct 24, 2014 | Siemens Healthcare Diagnostics, Inc. Dimension Vista HbA1c Terminated |
LCP | None listed |
| Jan 3, 2014 | Siemens Healthcare Diagnostics, Inc. HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems.
Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clin Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.