K213510 is an FDA 510(k) clearance for the IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA. 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 Products, Ltd. (Llanberis, GB). The FDA issued a Cleared decision on September 8, 2023, 675 days after receiving the submission on November 2, 2021.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K213510 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2021 |
| Decision Date | September 08, 2023 |
| Days to Decision | 675 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 |