K980240 is an FDA 510(k) clearance for the ELECSYS CA 125II ON THE ELECSYS 1010. This device is classified as a Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (Class II - Special Controls, product code LTK).
Submitted by Boehringer Mannheim Corp. (Pleasanton, US). The FDA issued a Cleared decision on March 25, 1998, 61 days after receiving the submission on January 23, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K980240 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1998 |
| Decision Date | March 25, 1998 |
| Days to Decision | 61 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 |