K200199 is an FDA 510(k) clearance for the ADVIA Centaur CA 125II. This device is classified as a Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (Class II - Special Controls, product code LTK).
Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on April 6, 2020, 70 days after receiving the submission on January 27, 2020.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K200199 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2020 |
| Decision Date | April 06, 2020 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | LTK — Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |