Submission Details
| 510(k) Number | K130332 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 11, 2013 |
| Decision Date | May 31, 2013 |
| Days to Decision | 109 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
VITROS CHEMISTRY PRODUCTS TRIG SLIDES
May 2013
Decision
109d
Days
Class 1
Risk
About This 510(k) Submission
K130332 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS TRIG SLIDES, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on May 31, 2013, 109 days after receiving the submission on February 11, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.
Device Classification
| Product Code | CDT — Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1705 |
Manufacturer
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