Submission Details
| 510(k) Number | K210858 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
VITROS Chemistry Products PHBR Slides
Aug 2021
Decision
143d
Days
Class 2
Risk
About This 510(k) Submission
K210858 is an FDA 510(k) clearance for the VITROS Chemistry Products PHBR Slides, 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 review panel. Regulated under 21 CFR 862.3660.
Device Classification
| Product Code | DLZ — Enzyme Immunoassay, Phenobarbital |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3660 |
Manufacturer
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