K130332 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS TRIG SLIDES. This device is classified as 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 FDA review panel. Regulated under 21 CFR 862.1705.
| 510(k) Number | K130332 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | CDT — Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1705 |