CIX — Bromcresol Green Dye-Binding, Albumin Class II
FDA product code CIX covers "Bromcresol Green Dye-Binding, Albumin", a Class II medical device regulated under 21 CFR 862.1035. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CIX
- Device Class
- Class II
- Regulation Number
- 862.1035
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251157 | truvian health | Core Metabolic | January 9, 2026 |
| K203248 | abbott ireland diagnostics division | Albumin BCG2 | November 23, 2021 |
| K200898 | medicon hellas | Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medic | September 21, 2021 |
| K191316 | ortho-clinical diagnostics | VITROS XT Chemistry Products ALB-TP Slides | June 7, 2019 |
| K170901 | biosystems | ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 | April 13, 2018 |
| K131488 | alfa wassermann diagnostics technologies | ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND | August 19, 2013 |
| K113374 | alfa wassermann diagnostic technologies | ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE P | July 13, 2012 |
| K110818 | polymedco | POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEI | September 8, 2011 |
| K110830 | elitechgroup | ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELI | June 21, 2011 |
| K101088 | medica | EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT | April 4, 2011 |
| K080874 | medica | EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT | February 20, 2009 |
| K072143 | alfa wassermann diagnostic technologies | S40 CLINICAL ANALYZER, S TEST ALB | July 14, 2008 |
| K060434 | horiba abx | ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, | June 5, 2007 |
| K033009 | roche diagnostics | ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 | October 16, 2003 |
| K030006 | elan diagnostics | ATAC PAK ALBUMIN REAGENT | March 7, 2003 |
| K023875 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4 | December 10, 2002 |
| K022072 | precision systems | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENT | August 23, 2002 |
| K012329 | wiener laboratories saic | WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 | September 21, 2001 |
| K011720 | olympus america | OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER | June 25, 2001 |
| K010877 | awareness technology | CHEMWELL, MODEL 2900 | May 23, 2001 |