510(k) K011852 ยท LCP Assay, Glycosylated Hemoglobin
DIMENSION HAIC ASSAY, MODEL DF105
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Nov 15, 2001 |
| Received | Jun 12, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011852
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2014 | Siemens Healthcare Diagnostics, Inc. HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems.
Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clini Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.