510(k) K103747
- Device
- ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS
- Applicant
- ELITECHGROUP SEPPIM S.A.S.
- 510(k) number
- K103747
- Product code
- LBS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-08-31
- Date received
- 2010-12-23
- Regulation
- 862.1475
- Classification name
- Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEBRA K HUTSON
- Address
- 21720 23rd Dr. SE Suite 150 Bothell WA US 98021 98021
FDA Registration Numbers#
- 8040374
- 3004192065
- 3005452690
- 8020316
- 3006716639
- 2030861
- 2517506
- 3023197868
- 3016438761
- 3005333358
- 3003539867
- 3006198300
- 3004493545
- 3011989923
- 9680746
- 3000308930
- 1319808
- 2085064
- 1616487
- 2027969
- 3002642396
- 1220972
- 3003593973
- 9610126
- 3003795116
- 1319809
- 2939693
- 3017379203
- 2032900
- 3012963943
- 1423455
- 3021841051
- 1827821
- 2250051
- 2247288
- 2050012
- 1063851
- 3015189693
- 9610529
- 2050010
- 3020978007
- 3007662974
- 1181055
- 2432235
- 1319681
Source Documents#
Other 510(k) Records For Product Code LBS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162593 | HDL-Cholesterol Gen.4 | Roche Diagnostics Operations (Rdo) | 2016-10-19 |
| K153435 | Direct HDL Cholesterol (HDL) | Randox Laboratories, Ltd. | 2016-01-08 |
| K132711 | CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT | Carolina Liquid Chemistries Corp. | 2014-05-08 |
| K120609 | VITROS CHEMISTRY PRODUCTS DHDL SLIDES | Ortho-Clinical Diagnostics, Inc. | 2012-09-07 |
| K111516 | NMR LIPOPROFILE (R) TEST AND NMR PROFILER | Liposcience, Inc. | 2011-09-27 |
| K111036 | EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT | Medica Corporation | 2011-07-12 |
| K100550 | POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC | Polymedco, Inc. | 2010-09-28 |
| K100010 | HDL CHOLESTEROL (HDLX) ASSAY | Beckman Coulter, Inc. | 2010-05-14 |
| K080125 | APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 | Wako Chemicals USA, Inc. | 2008-07-18 |
| K073497 | HDL CHOLESTEROL REAGENT, MODEL 10211 | Medica Corp. | 2008-04-14 |
| K072395 | DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS | Diazyme Laboratories | 2008-01-03 |
| K072836 | CHOLESTRAK HDL CHOLESTEROL HOME TEST | Accutech, LLC | 2007-12-27 |
| K071706 | ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) | Clinical Data, Inc. | 2007-12-20 |
| K062092 | PREVU POINT OF CARE SKIN STEROL TEST | Premd, Inc. | 2006-09-15 |
| K053157 | AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A | Dade Behring, Inc. | 2005-12-09 |
Legacy Summary#
summary
FDA Review#
Decision Summary