Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SL
FDA 510(k) K102993 · Seppim S.A.S.
510(k) numberK102993
Submission
- Device name
- Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SL
- Applicant
- Seppim S.A.S.
Bothell, WA, US - Received
- October 8, 2010
- Decision date
- May 19, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CDT – Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1705
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K150819 | TriglyceridesCDT · Traditional | Randox Laboratories Limited | 08/06/2015SE |
| K133067 | Advia Chemistry TRIGLYCERIDES_2 (TRIG_2) ReagentCDT · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/22/2013SE |
| K130332 | Vitros Chemistry Products Trig SlidesCDT · Special | Ortho-Clinical Diagnostics, Inc. | 05/31/2013SE |
| K113830 | Vantera Clinical AnalyzerCDT · Traditional | Liposcience | 08/30/2012SE |
| K063804 | Olympus Triglyceride Test SystemCDT · Traditional | Olympus America, Inc. | 03/23/2007SE |
| K043546 | Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer ModuleCDT · Special | Dade Behring, Inc. | 01/18/2005SE |
| K034000 | Vitalab Triglycerides Reagent and Vitalab CalibratorCDT · Traditional | Clinical Data, Inc. | 03/10/2004SE |
| K020488 | Careside TrglycerideCDT · Traditional | Careside, Inc. | 04/15/2002SE |
| K010871 | TGL Flex Reagent CartridgeCDT · Traditional | Dade Behring, Inc. | 07/09/2001SE |
| K993466 | Wako L-Type Triglyceride TestCDT · Traditional | Wako Chemicals USA, Inc. | 11/09/1999SE |
More from Wako Chemicals USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K103376 | Elitech Clinical Systems Creatinne Pap SL Model CRSL-0250, Clitech Clinical Systems…JFY · Traditional | 11/18/2011SE |
| K100547 | Elitech Clinical Systems HBA1C Reagent, Elitech Clincal System HBA1C Calibrator Set…LCP · Traditional | 05/19/2011SE |
| K100263 | Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsCEO · Traditional | 05/06/2011SE |
| K100525 | Elitech Clinical Systems Glucose Pap SL Elitech Clinical Systems Elical 2, Elitech…CGA · Traditional | 12/15/2010SE |
| K093883 | Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model ASSL-0250…CIT · Traditional | 09/20/2010SE |
Questions and answers
When was Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SL cleared by the FDA?
Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SL (K102993) received a 510(k) decision of Substantially Equivalent on May 19, 2011, 223 days after the submission was received.
What is the product code of K102993?
The FDA product code is CDT – Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, a Class I (low risk) device regulated under 21 CFR 862.1705.