510(k) K020828 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jul 24, 2002 |
| Received | Mar 14, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020828
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 21, 2018 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests) Terminated |
LTK | None listed |
| Mar 2, 2011 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur CA 125 II Assay packaged in 100 and 500 test kits as follows:
Product code: 09427226 (128532) 100 test kit
Product code: 01678114 (128533) 500 Test kit Terminated |
LTK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.