K133067 is an FDA 510(k) clearance for the ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT. This device is classified as a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I - General Controls, product code CDT).
Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on November 22, 2013, 56 days after receiving the submission on September 27, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1705.
| 510(k) Number | K133067 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2013 |
| Decision Date | November 22, 2013 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| 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 |