Submission Details
| 510(k) Number | K161140 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 22, 2016 |
| Decision Date | May 20, 2016 |
| Days to Decision | 28 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Abbreviated
VITROS Chemistry Products Calibrator Kit 3
May 2016
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K161140 is an FDA 510(k) clearance for the VITROS Chemistry Products Calibrator Kit 3, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on May 20, 2016, 28 days after receiving the submission on April 22, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.
Device Classification
| Product Code | JIX — Calibrator, Multi-analyte Mixture |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1150 |
Manufacturer
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