Elitechgroup
Medical device manufacturer in Bothell, WA.
18510(k) clearances
0PMA approvals
0recalls
Device types
- JIX Calibrator, Multi-Analyte Mixture 3
- CIG Diazo Colorimetry, Bilirubin 2
- JHW U.V. Method, Cpk Isoenzymes 2
- CIX Bromcresol Green Dye-Binding, Albumin 1
- JJY Multi-Analyte Controls, All Kinds (Assayed) 1
- KHS Enzymatic, Carbon-Dioxide 1
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 1
- JFJ Catalytic Methods, Amylase 1
- JIT Calibrator, Secondary 1
- JFY Enzymatic Method, Creatinine 1
- CJY Azo Dye, Calcium 1
- CFR Hexokinase, Glucose 1
- KTB Device, Iontophoresis, Specific Uses 1
- PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K180559 | HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusPGI · Traditional | 10/29/2018SE |
| K180627 | Macroduct Advanced Model 3710KTB · Traditional | 07/27/2018SE |
| K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT…CIG · Traditional | 07/11/2017SE |
| K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech…CFR · Traditional | 09/07/2016SE |
| K151113 | ELITech Clinical Systems CALCIUM ARSENAZOCJY · Traditional | 07/22/2015SE |
| K151552 | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical…JIX · Abbreviated | 07/08/2015SE |
| K141265 | Elitech Clinical Systems Envoy 500 CK Reagent KitJHW · Traditional | 07/18/2014SE |
| K132399 | Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine…JFY · Traditional | 01/03/2014SE |
| K130765 | Elitech Clinical Systems Elical 2; Elitech Clinical Systems Elitrol I, Elitech Clinical…JIX · Abbreviated | 04/04/2013SE |
| K122177 | Elitech Clinical Systems Urine Total Protein Plus Standard 100 Mg/Dl, Elitech Clinical…JIT · Abbreviated | 02/15/2013SE |
| K122858 | Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2 Eltech Clinical…JFJ · Traditional | 10/03/2012SE |
| K122083 | Elitech Clinical Systems CK Nac SLJHW · Traditional | 08/22/2012SE |
| K113269 | Elittech Clinical Systems Alp Ifcc SLCJE · Traditional | 12/29/2011SE |
| K111960 | Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise…KHS · Traditional | 11/18/2011SE |
| K110780 | Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech…CIG · Traditional | 10/07/2011SE |
| K111996 | Elitech Clinical Sysems Ise Control 1 and 2JJY · Abbreviated | 09/14/2011SE |
| K112029 | Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol I, Elitech Clinical…JIX · Abbreviated | 08/30/2011SE |
| K110830 | Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech…CIX · Traditional | 06/21/2011SE |