The following data is part of a premarket notification filed by Ortho Clinical Diagnostics with the FDA for Vitros Chemistry Products Crp Slides; Vitro Chemistry Products Calibrator Kit 7.
| Device ID | K152433 |
| 510k Number | K152433 |
| Device Name: | VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | ORTHO CLINICAL DIAGNOSTICS 100 INDIGO CREEK DRIVE Rochester, NY 14626 |
| Contact | Jessica Miller |
| Correspondent | Jessica Miller ORTHO CLINICAL DIAGNOSTICS 100 INDIGO CREEK DRIVE Rochester, NY 14626 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-27 |
| Decision Date | 2015-09-24 |
| Summary: | summary |