K210858 is an FDA 510(k) clearance for the VITROS Chemistry Products PHBR Slides. This device is classified as a Enzyme Immunoassay, Phenobarbital (Class II - Special Controls, product code DLZ).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on August 13, 2021, 143 days after receiving the submission on March 23, 2021.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3660.
| 510(k) Number | K210858 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2021 |
| Decision Date | August 13, 2021 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DLZ — Enzyme Immunoassay, Phenobarbital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3660 |