K072794 is an FDA 510(k) clearance for the IMMULITE 2500 OM-MA, MODEL L5KOP. This device is classified as a Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (Class II — Special Controls, product code LTK).
Submitted by Siemens Medical Solutions Diagnostics (Los Angeles, US). The FDA issued a Cleared decision on November 5, 2007, 35 days after receiving the submission on October 1, 2007.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K072794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent — Traditional 510(k) (SESE) |
| Date Received | October 01, 2007 |
| Decision Date | November 05, 2007 |
| Days to Decision | 35 days |
| Submission Type | Special |
| 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 |