K041322 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS. 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 17, 2004, 30 days after receiving the submission on May 18, 2004.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K041322 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2004 |
| Decision Date | June 17, 2004 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |