Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus Calibrators 1 & 2, Models A15625/A16747
FDA 510(k) K042195 · Beckman Coulter, Inc.
510(k) numberK042195
Submission
- Device name
- Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus Calibrators 1 & 2, Models A15625/A16747
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- August 13, 2004
- Decision date
- September 16, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LBS – Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K162593 | HDL-Cholesterol Gen.4LBS · Traditional | Roche Diagnostics Operations (Rdo) | 10/19/2016SE |
| K153435 | Direct HDL Cholesterol (HDL)LBS · Traditional | Randox Laboratories, Ltd. | 01/08/2016SE |
| K132711 | Carolina Liquid Chemistries HDL Cholesterol ReagentLBS · Traditional | Carolina Liquid Chemistries Corp. | 05/08/2014SE |
| K120609 | Vitros Chemistry Products DHDL SlidesLBS · Special | Ortho-Clinical Diagnostics, Inc. | 09/07/2012SE |
| K111516 | NMR Lipoprofile (R) Test and NMR ProfilerLBS · Traditional | Liposcience, Inc. | 09/27/2011SE |
| K103747 | Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G, LDL 2G…LBS · Traditional | Elitechgroup Seppim S.A.S. | 08/31/2011SE |
| K111036 | Easyra HDL Reagent; Easyra LDL Reagent; Easyra Chol Reagent; Easyra Trig ReagentLBS · Traditional | Medica Corporation | 07/12/2011SE |
| K100550 | Poly-Chem 90 Direct HDL Cholesterol, Poly-Chem 90 Direct LDL Cholesterol, Poly-Chem 90…LBS · Traditional | Polymedco, Inc. | 09/28/2010SE |
| K100010 | HDL Cholesterol (HDLX) AssayLBS · Traditional | Beckman Coulter, Inc. | 05/14/2010SE |
| K080125 | Apolowako T-Cho, Hdl-C, TG and Analyzer, Models 993-23501, 999-23601, 995-23701 and…LBS · Traditional | Wako Chemicals USA, Inc. | 07/18/2008SE |
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Questions and answers
When was Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus Calibrators 1 & 2, Models A15625/A16747 cleared by the FDA?
Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus Calibrators 1 & 2, Models A15625/A16747 (K042195) received a 510(k) decision of Substantially Equivalent on September 16, 2004, 34 days after the submission was received.
What is the product code of K042195?
The FDA product code is LBS – Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl, a Class I (low risk) device regulated under 21 CFR 862.1475.