510(k) K131307 ยท LCP Assay, Glycosylated Hemoglobin
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jan 24, 2014 |
| Received | May 7, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131307
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2022 | Siemens Healthcare Diagnostics, Inc. Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637 Open, Classified |
LCP | None listed |
| Oct 13, 2020 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems
Sieme Open, Classified |
JIT | None listed |
| Oct 13, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems
Siemens M Open, Classified |
JIT | None listed |
| Jun 5, 2020 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative measurement of glycated protein (fructosamine) in huma Terminated |
LCP | None listed |
| Jun 5, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma fo Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.