Submission Details
| 510(k) Number | K102993 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 08, 2010 |
| Decision Date | May 19, 2011 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL
May 2011
Decision
223d
Days
Class 1
Risk
About This 510(k) Submission
K102993 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Seppim S.A.S. (Bothell, US). The FDA issued a Cleared decision on May 19, 2011, 223 days after receiving the submission on October 8, 2010. 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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