The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Calibrator Kit 3.
| Device ID | K161140 |
| 510k Number | K161140 |
| Device Name: | VITROS Chemistry Products Calibrator Kit 3 |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | ORTHO-CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DRIVE Rochester, NY 14626 -5101 |
| Contact | Marlene Hanna |
| Correspondent | Marlene Hanna ORTHO-CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DRIVE Rochester, NY 14626 -5101 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-22 |
| Decision Date | 2016-05-20 |
| Summary: | summary |