510(k) K013406 ยท LPS Urinary Homocystine (Nonquantitative) Test System
ADVIA CENTAUR HOMOCYSTEINE ASSAY
| Applicant | Bayer Diagnostics Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Dec 18, 2001 |
| Received | Oct 15, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013406
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2025 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376. Open, Classified |
JIS | None listed |
| Jul 2, 2014 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP Terminated |
LPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.