The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Crbm Slides, Vitros Chemistry Products Crea Slides, Vitros Chemistry Products Tbil Slides, Vitros Xt 7600 Integrated System.
| Device ID | K182063 |
| 510k Number | K182063 |
| Device Name: | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System |
| Classification | Enzymatic Method, Creatinine |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626 |
| Contact | Marlene Hanna |
| Correspondent | Marlene Hanna Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626 |
| Product Code | JFY |
| Subsequent Product Code | CIG |
| Subsequent Product Code | JJE |
| Subsequent Product Code | KLT |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-01 |
| Decision Date | 2018-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750031986 | K182063 | 000 |
| 10758750031610 | K182063 | 000 |