The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros 5,1 Fs Chemistry System With Engen Laboratory Automation System.
| Device ID | K063144 |
| 510k Number | K063144 |
| Device Name: | VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Sarah C Parsons |
| Correspondent | Sarah C Parsons Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | JJE |
| Subsequent Product Code | JIT |
| Subsequent Product Code | LBR |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-16 |
| Decision Date | 2006-11-13 |
| Summary: | summary |