Submission Details
| 510(k) Number | K182063 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 01, 2018 |
| Decision Date | October 30, 2018 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System
Oct 2018
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K182063 is an FDA 510(k) clearance for the VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System, a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on October 30, 2018, 90 days after receiving the submission on August 1, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.
Device Classification
| Product Code | JFY — Enzymatic Method, Creatinine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1225 |
Manufacturer
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