510(k) K023891 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
| Applicant | Tosoh Medics, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Dec 6, 2002 |
| Received | Nov 22, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023891
No recall in the FDA data names this 510(k).
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