Poly-Chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, and Total Protein Tests
FDA 510(k) K110818 · Polymedco, Inc.
510(k) numberK110818
Submission
- Device name
- Poly-Chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, and Total Protein Tests
- Applicant
- Polymedco, Inc.
Cortlandt Manor, NY, US - Received
- March 24, 2011
- Decision date
- September 8, 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
| 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 |
| K110830 | Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech…CIX · Traditional | Elitechgroup | 06/21/2011SE |
| 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 |
|---|---|---|
| K112408 | Poly-Chem 90 Ise ModuleCEM · Traditional | 11/04/2011SE |
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| K100550 | Poly-Chem 90 Direct HDL Cholesterol, Poly-Chem 90 Direct LDL Cholesterol, Poly-Chem 90…LBS · Traditional | 09/28/2010SE |
| K090703 | Poly-Chem 90 GlucoseCFR · Traditional | 10/20/2009SE |
| K061944 | Poly-Chem CreatinineJFY · Traditional | 11/03/2006SE |
| K053553 | Nycocard U-Albumin and U-Albumin ControlDCF · Traditional | 03/09/2006SE |
| K041408 | Polymedco Oc Auto Micro 80 Fob TestOOX · Traditional | 10/21/2004SE |
| K041297 | Polymedco Oc Light Fobt TestKHE · Traditional | 08/12/2004SE |
| K033706 | Polymedco Homocysteine Test for the Poly-Chem and Hitachi Chemistry SystemsLPS · Traditional | 02/04/2004SE |
| K023654 | Glyca-Direct FructosamineLCP · Traditional | 05/02/2003SE |
Questions and answers
When was Poly-Chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, and Total Protein Tests cleared by the FDA?
Poly-Chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, and Total Protein Tests (K110818) received a 510(k) decision of Substantially Equivalent on September 8, 2011, 168 days after the submission was received.
What is the product code of K110818?
The FDA product code is CIX – Bromcresol Green Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.