Submission Details
| 510(k) Number | K953971 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 23, 1995 |
| Decision Date | April 05, 1996 |
| Days to Decision | 226 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY
Apr 1996
Decision
226d
Days
Class 1
Risk
About This 510(k) Submission
K953971 is an FDA 510(k) clearance for the TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION 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 April 5, 1996, 226 days after receiving the submission on August 23, 1995. 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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