The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Immunodiagnostic Products Free T3 Reagent Pack, Vitros Immunodiagnostic Products Free T3 Calibrators.
| Device ID | K994145 |
| 510k Number | K994145 |
| Device Name: | VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS |
| Classification | Calibrator, Primary |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Marlene A Shulman |
| Correspondent | Marlene A Shulman Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-08 |
| Decision Date | 1999-12-22 |
| Summary: | summary |