K990943 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK. This device is classified as a System, Test, Carcinoembryonic Antigen (Class II - Special Controls, product code DHX).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on June 1, 1999, 71 days after receiving the submission on March 22, 1999.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K990943 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 1999 |
| Decision Date | June 01, 1999 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DHX — System, Test, Carcinoembryonic Antigen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |