The following data is part of a premarket notification filed by Ortho Clinical Diagnostics with the FDA for Vitros Immunodiagnostic Products Insulin Calibrators.
| Device ID | K171168 |
| 510k Number | K171168 |
| Device Name: | VITROS Immunodiagnostic Products Insulin Calibrators |
| Classification | Calibrator, Secondary |
| Applicant | Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626 |
| Contact | Bradley P. Boyer |
| Correspondent | Bradley P. Boyer Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-21 |
| Decision Date | 2017-05-16 |
| Summary: | summary |