The following data is part of a premarket notification filed by Ortho-clinical Diagnostics with the FDA for The Vitros 5,1 Fs Chemistry System.
| Device ID | K041764 |
| 510k Number | K041764 |
| Device Name: | THE VITROS 5,1 FS CHEMISTRY SYSTEM |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Carey A Mayo |
| Correspondent | Carey A Mayo ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | LCP |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-30 |
| Decision Date | 2004-09-09 |
| Summary: | summary |