The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products K+dt Slides: Vitros Chemistry Products Dt Calibrator Kit, Model K+dt Slides: 153 2258.
| Device ID | K083680 |
| 510k Number | K083680 |
| Device Name: | VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. MC 00882 Rochester, NY 14626 -5101 |
| Contact | Marlene A Hanna |
| Correspondent | Marlene A Hanna Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. MC 00882 Rochester, NY 14626 -5101 |
| Product Code | CEM |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-12 |
| Decision Date | 2009-02-27 |
| Summary: | summary |