510(k) K971418 ยท MOI System, Test, Immunological, Antigen, Tumor
CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER
| Applicant | Chiron Diagnostics Corp., Medfield MA, US |
| Decision | Substantially Equivalent, Jul 17, 1997 |
| Received | Apr 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971418
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2014 | Siemens Healthcare Diagnostics ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb. Terminated |
JJE | None listed |
| May 6, 2008 | Siemens Medical Solutions Diagnostics ADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591. Terminated |
LOL | None listed |
| Mar 22, 2007 | Siemens Healthcare Diagnostics ADVIA Centaur CP System, Catalog/Part Number 086-A001. Automated Immunoassay Analyzer. --- Classification of the Device: Under 21 CFR, Part 862.2160, the ADVIA Centaur CP is a discrete photometric c Terminated |
JJE | None listed |
| Sep 23, 2006 | Siemens Healthcare Diagnostics ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001. Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.