K042731 is an FDA 510(k) clearance for the ARCHITECT CA 125 II ASSAY. This device is classified as a Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (Class II - Special Controls, product code LTK).
Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on November 19, 2004, 49 days after receiving the submission on October 1, 2004.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K042731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2004 |
| Decision Date | November 19, 2004 |
| Days to Decision | 49 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 |