Submission Details
| 510(k) Number | K191316 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 15, 2019 |
| Decision Date | June 07, 2019 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
VITROS XT Chemistry Products ALB-TP Slides
Jun 2019
Decision
23d
Days
Class 2
Risk
About This 510(k) Submission
K191316 is an FDA 510(k) clearance for the VITROS XT Chemistry Products ALB-TP Slides, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on June 7, 2019, 23 days after receiving the submission on May 15, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.
Device Classification
| Product Code | CIX — Bromcresol Green Dye-binding, Albumin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1035 |
Manufacturer
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