Easyra Albumin, Calcium, Magnesium and Inorganic Phosphorous Reagent
FDA 510(k) K101088 · Medica Corp.
510(k) numberK101088
Submission
- Device name
- Easyra Albumin, Calcium, Magnesium and Inorganic Phosphorous Reagent
- Applicant
- Medica Corp.
Bedford, MA, US - Received
- April 19, 2010
- Decision date
- April 4, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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|---|---|---|---|
| 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 |
| K110830 | Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech…CIX · Traditional | Elitechgroup | 06/21/2011SE |
| 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 |
|---|---|---|
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| K211559 | EasyStat 300CHL · Traditional | 01/27/2023SE |
| K152327 | EasyLyte Na/K/Cl/Ca AnalyzerJFP · Traditional | 12/01/2016SE |
| K130080 | Easyra Ck-Mb Reagent, Easyra CRP Reagent, Easy Cal CRP Calibrator Kit, Easyqc CRP…JHY · Traditional | 05/13/2014SE |
| K123586 | Easyra Creatinine ReagentCGX · Special | 05/15/2013SE |
| K123802 | Easyra Tbil Reagent, Easyra Dbii Reagent, Easyra CK ReagentCIG · Traditional | 03/01/2013SE |
| K120497 | Easyra Hbalc Regent Easycal HBLC Calibrator Easyqc Hbalc MaterialLCP · Traditional | 05/14/2012SE |
| K111363 | PPX Reagent, PPX Calibrators, PPX QC MaterialJXN · Traditional | 12/06/2011SE |
| K111005 | Ethanol Reagent, Ethanol Calibrator, Ethanol QC MaterialDIC · Traditional | 11/15/2011SE |
Questions and answers
When was Easyra Albumin, Calcium, Magnesium and Inorganic Phosphorous Reagent cleared by the FDA?
Easyra Albumin, Calcium, Magnesium and Inorganic Phosphorous Reagent (K101088) received a 510(k) decision of Substantially Equivalent on April 4, 2011, 350 days after the submission was received.
What is the product code of K101088?
The FDA product code is CIX – Bromcresol Green Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.