K081294 is an FDA 510(k) clearance for the ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS. This device is classified as a Cardiac C-reactive Protein, Antigen, Antiserum, And Control (Class II - Special Controls, product code NQD).
Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on July 29, 2008, 83 days after receiving the submission on May 7, 2008.
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 | K081294 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2008 |
| Decision Date | July 29, 2008 |
| Days to Decision | 83 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. |