510(k) K022329 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
| Applicant | Bayer Diagnostics Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Nov 27, 2002 |
| Received | Jul 18, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022329
No recall in the FDA data names this 510(k).
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