K983690 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK. This device is classified as a System, Test, Immunological, Antigen, Tumor (Class II - Special Controls, product code MOI).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on February 2, 1999, 104 days after receiving the submission on October 21, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K983690 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1998 |
| Decision Date | February 02, 1999 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | MOI — System, Test, Immunological, Antigen, Tumor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |