Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech Clinical Systems Elical 2; Elitech
FDA 510(k) K110830 · Elitechgroup
510(k) numberK110830
Submission
- Device name
- Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech Clinical Systems Elical 2; Elitech
- Applicant
- Elitechgroup
Bothell, WA, US - Received
- March 25, 2011
- Decision date
- June 21, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CIX – Bromcresol Green Dye-Binding, Albumin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1035
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251157 | Core MetabolicCIX · Traditional | Truvian Health | 01/09/2026SE |
| K203248 | Albumin BCG2CIX · Traditional | Abbott Ireland Diagnostics Division | 11/23/2021SE |
| K200898 | Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon…CIX · Traditional | Medicon Hellas S.A | 09/21/2021SE |
| K191316 | VITROS XT Chemistry Products ALB-TP SlidesCIX · Traditional | Ortho-Clinical Diagnostics, Inc. | 06/07/2019SE |
| K170901 | Albumin, Alkaline Phosphatase (Alp)-Amp, Glucose-Hexokinase, BA400CIX · Traditional | Biosystems S.A. | 04/13/2018SE |
| K131488 | Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo Reagent and Ace…CIX · Traditional | Alfa Wassermann Diagnostics Technologies, LLC | 08/19/2013SE |
| K113374 | Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace…CIX · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 07/13/2012SE |
| K110818 | Poly-Chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, and Total Protein TestsCIX · Traditional | Polymedco, Inc. | 09/08/2011SE |
| K101088 | Easyra Albumin, Calcium, Magnesium and Inorganic Phosphorous ReagentCIX · Traditional | Medica Corp. | 04/04/2011SE |
| K080874 | Easyra Alb Reagent and Easyra Alp Reagent, Model 10218/10214, Easyra Ast Reagent, Model…CIX · Traditional | Medica Corp. | 02/20/2009SE |
More from Medica Corp.
| 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 |
Questions and answers
When was Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech Clinical Systems Elical 2; Elitech cleared by the FDA?
Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech Clinical Systems Elical 2; Elitech (K110830) received a 510(k) decision of Substantially Equivalent on June 21, 2011, 88 days after the submission was received.
What is the product code of K110830?
The FDA product code is CIX – Bromcresol Green Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.