K983031 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY. This device is classified as a Kit, Test,alpha-fetoprotein For Testicular Cancer (Class II - Special Controls, product code LOJ).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on December 18, 1998, 109 days after receiving the submission on August 31, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K983031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 1998 |
| Decision Date | December 18, 1998 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | LOJ — Kit, Test,alpha-fetoprotein For Testicular Cancer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |