Albumin BCG2
FDA 510(k) K203248 · Abbott Ireland Diagnostics Division
510(k) numberK203248
Submission
- Device name
- Albumin BCG2
- Applicant
- Abbott Ireland Diagnostics Division
Longford, IE - Received
- November 4, 2020
- Decision date
- November 23, 2021
- 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 |
| 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 |
| 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 |
|---|---|---|
| K223317 | Alkaline Phosphatase2CJE · Traditional | 07/21/2023SE |
| K223324 | Total Bilirubin2CIG · Traditional | 12/29/2022SE |
| K203597 | Cholesterol2CHH · Traditional | 06/30/2022SE |
| K203771 | Urea Nitrogen2CDQ · Traditional | 05/31/2022SE |
| K210633 | Amylase2JFJ · Traditional | 05/26/2022SE |
| K210452 | Creatinine2CGX · Traditional | 03/22/2022SE |
| K203530 | Albumin BCP2CJW · Traditional | 03/18/2022SE |
Questions and answers
When was Albumin BCG2 cleared by the FDA?
Albumin BCG2 (K203248) received a 510(k) decision of Substantially Equivalent on November 23, 2021, 384 days after the submission was received.
What is the product code of K203248?
The FDA product code is CIX – Bromcresol Green Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.