K071002 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT. This device is classified as a Cardiac C-reactive Protein, Antigen, Antiserum, And Control (Class II - Special Controls, product code NQD).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on June 21, 2007, 73 days after receiving the submission on April 9, 2007.
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 | K071002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2007 |
| Decision Date | June 21, 2007 |
| Days to Decision | 73 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. |