Submission Details
| 510(k) Number | K120765 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 13, 2012 |
| Decision Date | October 24, 2012 |
| Days to Decision | 225 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
Oct 2012
Decision
225d
Days
Class 2
Risk
About This 510(k) Submission
K120765 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS ECO2 SLIDES, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on October 24, 2012, 225 days after receiving the submission on March 13, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.
Device Classification
| Product Code | KHS — Enzymatic, Carbon-dioxide |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1160 |
Manufacturer
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