Envoy 500 HDL; Cholesterol Reagent Kit (Model# 55301), Calibrator Kit (Model# 55118)
FDA 510(k) K071706 · Clinical Data, Inc.
510(k) numberK071706
Submission
- Device name
- Envoy 500 HDL; Cholesterol Reagent Kit (Model# 55301), Calibrator Kit (Model# 55118)
- Applicant
- Clinical Data, Inc.
Brea, CA, US - Received
- June 21, 2007
- Decision date
- December 20, 2007
- 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
Other 510(k)s with product code LBS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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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| K040631 | Vitalab Direct Bilirubin ReagentCIG · Traditional | 03/18/2004SE |
| K040534 | Vitalab Amylase ReagentJFJ · Traditional | 03/11/2004SE |
| K034000 | Vitalab Triglycerides Reagent and Vitalab CalibratorCDT · Traditional | 03/10/2004SE |
| K040508 | Vitalab Magnesium ReagentJGJ · Traditional | 03/08/2004SE |
| K040467 | Vitalab Uric Acid ReagentKNK · Traditional | 03/08/2004SE |
| K031042 | Atac Hemoglobin A1C Reagent KitLCP · Traditional | 11/03/2003SE |
| K031044 | Atac Pak Uric Acid Reagent and Atac CalibratorKNK · Traditional | 07/15/2003SE |
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Questions and answers
When was Envoy 500 HDL; Cholesterol Reagent Kit (Model# 55301), Calibrator Kit (Model# 55118) cleared by the FDA?
Envoy 500 HDL; Cholesterol Reagent Kit (Model# 55301), Calibrator Kit (Model# 55118) (K071706) received a 510(k) decision of Substantially Equivalent on December 20, 2007, 182 days after the submission was received.
What is the product code of K071706?
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.