K041155 is an FDA 510(k) clearance for the WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY. This device is classified as a C-reactive Protein, Antigen, Antiserum, And Control (Class II - Special Controls, product code DCK).
Submitted by Stanbio Laboratory (Boerne, US). The FDA issued a Cleared decision on October 14, 2004, 164 days after receiving the submission on May 3, 2004.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K041155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2004 |
| Decision Date | October 14, 2004 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DCK — C-reactive Protein, Antigen, Antiserum, And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |