K152433 is an FDA 510(k) clearance for the VITROS Chemistry Products CRP Slides. This device is classified as a C-reactive Protein, Antigen, Antiserum, And Control (Class II - Special Controls, product code DCK).
Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on September 24, 2015, 28 days after receiving the submission on August 27, 2015.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K152433 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 2015 |
| Decision Date | September 24, 2015 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |