K032336 is an FDA 510(k) clearance for the TINA-QUANT CRP (LATEX). This device is classified as a System, Test, C-reactive Protein (Class II - Special Controls, product code DCN).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 5, 2003, 7 days after receiving the submission on July 29, 2003.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K032336 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2003 |
| Decision Date | August 05, 2003 |
| Days to Decision | 7 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DCN — System, Test, C-reactive Protein |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |