Submission Details
| 510(k) Number | K190520 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 04, 2019 |
| Decision Date | April 03, 2019 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
VITROS XT Chemistry Products GLU-Ca Slides
Apr 2019
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K190520 is an FDA 510(k) clearance for the VITROS XT Chemistry Products GLU-Ca Slides, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on April 3, 2019, 30 days after receiving the submission on March 4, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.
Device Classification
| Product Code | CGA — Glucose Oxidase, Glucose |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1345 |
Manufacturer
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