K042485 is an FDA 510(k) clearance for the TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE). This device is classified as a Cardiac C-reactive Protein, Antigen, Antiserum, And Control (Class II - Special Controls, product code NQD).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 29, 2004, 46 days after receiving the submission on September 13, 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 | K042485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2004 |
| Decision Date | October 29, 2004 |
| Days to Decision | 46 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. |