K990431 is an FDA 510(k) clearance for the AIA-PACK CA 125. This device is classified as a Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (Class II - Special Controls, product code LTK).
Submitted by Tosoh Medics, Inc. (South San Francisco, US). The FDA issued a Cleared decision on June 3, 1999, 112 days after receiving the submission on February 11, 1999.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K990431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 1999 |
| Decision Date | June 03, 1999 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LTK — Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |