K113809 is an FDA 510(k) clearance for the HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP). This device is classified as a System, Test, C-reactive Protein (Class II - Special Controls, product code DCN).
Submitted by Hitachi Chemical Diagnostics, Inc. (Los Angeles, US). The FDA issued a Cleared decision on August 17, 2012, 238 days after receiving the submission on December 23, 2011.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K113809 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2011 |
| Decision Date | August 17, 2012 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DCN — System, Test, C-reactive Protein |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |