K003400 is an FDA 510(k) clearance for the CRP HS TEST SYSTEM. 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 May 10, 2001, 190 days after receiving the submission on November 1, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K003400 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2000 |
| Decision Date | May 10, 2001 |
| Days to Decision | 190 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 |