Submission Details
| 510(k) Number | K961477 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 18, 1996 |
| Decision Date | August 05, 1996 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY
Aug 1996
Decision
109d
Days
Class 1
Risk
About This 510(k) Submission
K961477 is an FDA 510(k) clearance for the TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Trace America, Inc. (Miami, US). The FDA issued a Cleared decision on August 5, 1996, 109 days after receiving the submission on April 18, 1996. 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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