The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Na + Dt Slides, Model 153 2290 And Dt Calibrator Kit, Model 195 7927.
| Device ID | K091861 |
| 510k Number | K091861 |
| Device Name: | VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927 |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Marlene A Hanna |
| Correspondent | Marlene A Hanna Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-19 |
| Decision Date | 2009-09-03 |
| Summary: | summary |