The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Xt Chemistry Products Tbil-alkp Slides.
| Device ID | K190807 |
| 510k Number | K190807 |
| Device Name: | VITROS XT Chemistry Products TBIL-ALKP Slides |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626 |
| Contact | Darlene Phillips |
| Correspondent | Darlene Phillips Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-29 |
| Decision Date | 2019-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750031801 | K190807 | 000 |