K952741 is an FDA 510(k) clearance for the TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM. This device is classified as a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I - General Controls, product code CDT).
Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on August 17, 1995, 62 days after receiving the submission on June 16, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1705.
| 510(k) Number | K952741 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 1995 |
| Decision Date | August 17, 1995 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CDT — Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1705 |