The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Phbr Slides.
| Device ID | K210858 |
| 510k Number | K210858 |
| Device Name: | VITROS Chemistry Products PHBR Slides |
| Classification | Enzyme Immunoassay, Phenobarbital |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626 -5101 |
| Contact | Darlene Phillips |
| Correspondent | Darlene Phillips Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626 -5101 |
| Product Code | DLZ |
| CFR Regulation Number | 862.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-23 |
| Decision Date | 2021-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750004560 | K210858 | 000 |