Panels › Clinical Chemistry › Product code CIX · Class 2
Bromcresol Green Dye-Binding, Albumin
Regulation 862.1035
1510(k)s in 12 months (120 all time)
0recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in CIX
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 9, 2026 | K251157 | Core Metabolic Truvian Health | CIX |
| Nov 23, 2021 | K203248 | Albumin BCG2 Abbott Ireland Diagnostics Division, IE | CIX |
| Sep 21, 2021 | K200898 | Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Medicon Hellas S.A, GR | CIX |
| Jun 7, 2019 | K191316 | VITROS XT Chemistry Products ALB-TP Slides Ortho-Clinical Diagnostics, Inc. | CIX |
| Apr 13, 2018 | K170901 | ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 Biosystems S.A., ES | CIX |
| Aug 19, 2013 | K131488 | ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT Alfa Wassermann Diagnostics Technologies, LLC | CIX |
| Jul 13, 2012 | K113374 | ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT Alfa Wassermann Diagnostic Technologies, Inc. | CIX |
| Sep 8, 2011 | K110818 | POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS Polymedco, Inc. | CIX |
| Jun 21, 2011 | K110830 | ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH Elitechgroup | CIX |
| Apr 4, 2011 | K101088 | EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT Medica Corp. | CIX |
| Feb 20, 2009 | K080874 | EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT Medica Corp. | CIX |
| Jul 14, 2008 | K072143 | S40 CLINICAL ANALYZER, S TEST ALB Alfa Wassermann Diagnostic Technologies, Inc. | CIX |
| Jun 5, 2007 | K060434 | ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL Horiba Abx, FR | CIX |
| Oct 16, 2003 | K033009 | ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 Roche Diagnostics Corp. | CIX |
| Mar 7, 2003 | K030006 | ATAC PAK ALBUMIN REAGENT Elan Diagnostics | CIX |
| Dec 10, 2002 | K023875 | VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4 Ortho-Clinical Diagnostics, Inc. | CIX |
| Aug 23, 2002 | K022072 | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS Precision Systems, Inc. | CIX |
| Sep 21, 2001 | K012329 | WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 Wiener Laboratories Saic, AR | CIX |
| Jun 25, 2001 | K011720 | OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc. | CIX |
| May 23, 2001 | K010877 | CHEMWELL, MODEL 2900 Awareness Technology, Inc. | CIX |
| Dec 5, 2000 | K003327 | ALBUMIN Jas Diagnostics, Inc. | CIX |
| Sep 15, 1999 | K992399 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM Bayer Corp. | CIX |
| Jun 30, 1999 | K991576 | ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM Bayer Corp. | CIX |
| Mar 23, 1999 | K984494 | RANDOX ALBUMIN Randox Laboratories, Ltd., GB | CIX |
| Jun 12, 1998 | K981758 | ALBG Abbott Laboratories | CIX |
| May 27, 1998 | K981468 | ALBG Abbott Laboratories | CIX |
| Feb 4, 1998 | K980041 | CARESIDE ALBUMIN Exigent Diagnostics, Inc. | CIX |
| May 2, 1997 | K971445 | ALB OR ALBUMIN Carolina Liquid Chemistries Corp. | CIX |
| Mar 13, 1996 | K955781 | ALBUMIN Derma Media Lab., Inc. | CIX |
| Oct 13, 1995 | K952488 | TRACE COBAS MIRA RANGE Trace Scientific , Ltd. | CIX |
| Mar 1, 1995 | K946355 | DMA ALBUMIN PROCEDURE Data Medical Associates, Inc. | CIX |
| Dec 13, 1994 | K943000 | ALBUMIN QVET Prisma Systems | CIX |
| Dec 17, 1993 | K935179 | EMDS ALBUMIN (ALB) TEST Em Diagnostic Systems, Inc. | CIX |
| Feb 8, 1993 | K924368 | OLYMPUS ALBUMIN REAGENT Olympus Corp. | CIX |
| Dec 28, 1992 | K923959 | ALBUMIN TEST Em Diagnostic Systems, Inc. | CIX |
| Sep 11, 1992 | K923322 | TRACE ALBUMIN-MR REAGENT Trace Scientific , Ltd. | CIX |
| Jul 17, 1992 | K922369 | OLYMPUS ALBUMIN REAGENT Olympus Corp. | CIX |
| Nov 27, 1991 | K914888 | TECHNICON CHEM 1(TM) SYST (GEN2 SYST) Technicon Instruments Corp. | CIX |
| Sep 27, 1991 | K913920 | ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37 Em Diagnostic Systems, Inc. | CIX |
| Aug 26, 1991 | K913195 | KODAK EKTACHEM DT SLIDES (ALB) Eastman Kodak Company | CIX |
| Jan 25, 1991 | K905660 | SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401 Em Diagnostic Systems, Inc. | CIX |
| Oct 12, 1990 | K903543 | SYNERMED ALBUMIN REAGENT KIT Synermed, Inc., CA | CIX |
| May 30, 1990 | K901268 | COULTER ALBUMIN REAGENT Coulter Corp. | CIX |
| Feb 27, 1990 | K896235 | COBAS READY ALBUMIN REAGENT Roche Diagnostic Systems, Inc. | CIX |
| Jan 18, 1990 | K896910 | CLINISTAT ALBUMIN REAGENT TEST Miles Diagnostics Div. | CIX |
| Aug 21, 1989 | K893777 | ALBUMIN TEST (ALB) ITEM NUMBER: 65401 Em Diagnostic Systems, Inc. | CIX |
| May 5, 1989 | K891375 | IQ ALBUMIN Bd Becton Dickinson Vacutainer Systems Preanalytic | CIX |
| Feb 10, 1989 | K885094 | BIOTROL ALBUMIN Biotrol, USA, Inc. | CIX |
| Jan 11, 1989 | K884705 | ALBUMIN TEST (ALB) ITEM #65650 Em Diagnostic Systems, Inc. | CIX |
| Aug 8, 1988 | K882587 | A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM A-Kem, Inc. | CIX |
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