Submission Details
| 510(k) Number | K190490 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 28, 2019 |
| Decision Date | March 27, 2019 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
VITROS XT Chemistry Products TRIG-CHOL Slides
Mar 2019
Decision
27d
Days
Class 1
Risk
About This 510(k) Submission
K190490 is an FDA 510(k) clearance for the VITROS XT Chemistry Products TRIG-CHOL Slides, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on March 27, 2019, 27 days after receiving the submission on February 28, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.
Device Classification
| Product Code | CHH — Enzymatic Esterase--oxidase, Cholesterol |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1175 |
Manufacturer
Ortho-Clinical Diagnostics, Inc.
Rochester, NY · US
Alexandra Chamberlain
106 submissions
104 cleared
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