K041799 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS. This device is classified as a Cardiac C-reactive Protein, Antigen, Antiserum, And Control (Class II - Special Controls, product code NQD).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on August 25, 2004, 54 days after receiving the submission on July 2, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5270. In Vitro Diagnostic Test To Measure C-reactive Protein For The Purpose Of Making Cardiac Risk Assessments..
| 510(k) Number | K041799 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2004 |
| Decision Date | August 25, 2004 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NQD — Cardiac C-reactive Protein, Antigen, Antiserum, And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |
| Definition | In Vitro Diagnostic Test To Measure C-reactive Protein For The Purpose Of Making Cardiac Risk Assessments. |