Submission Details
| 510(k) Number | K190807 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 29, 2019 |
| Decision Date | April 26, 2019 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
VITROS XT Chemistry Products TBIL-ALKP Slides
Apr 2019
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K190807 is an FDA 510(k) clearance for the VITROS XT Chemistry Products TBIL-ALKP Slides, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on April 26, 2019, 28 days after receiving the submission on March 29, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.
Device Classification
| Product Code | CIG — Diazo Colorimetry, Bilirubin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1110 |
Manufacturer
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