Atlas FDA

CIX

120 FDA 510(k) clearances · Product code

42 daysmedian time to decision
168 days90th percentile
120clearances measured

FDA profile

Official device name
Bromcresol Green Dye-Binding, Albumin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1035
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2010: 74 · 2011: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Core Metabolic (K251157)Truvian Health2026-01-09
Albumin BCG2 (K203248)Abbott Ireland Diagnostics Division2021-11-23
Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin (K200898)Medicon Hellas S.A2021-09-21
VITROS XT Chemistry Products ALB-TP Slides (K191316)Ortho-Clinical Diagnostics, Inc.2019-06-07
ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 (K170901)Biosystems S.A.2018-04-13
ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT (K131488)Alfa Wassermann Diagnostics Technologies, LLC2013-08-19
ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT (K113374)Alfa Wassermann Diagnostic Technologies, Inc.2012-07-13
POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS (K110818)Polymedco, Inc.2011-09-08
ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH (K110830)Elitechgroup2011-06-21
EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT (K101088)Medica Corp.2011-04-04
EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT (K080874)Medica Corp.2009-02-20
S40 CLINICAL ANALYZER, S TEST ALB (K072143)Alfa Wassermann Diagnostic Technologies, Inc.2008-07-14
ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL (K060434)Horiba Abx2007-06-05
ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 (K033009)Roche Diagnostics Corp.2003-10-16
ATAC PAK ALBUMIN REAGENT (K030006)Elan Diagnostics2003-03-07
VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4 (K023875)Ortho-Clinical Diagnostics, Inc.2002-12-10
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS (K022072)Precision Systems, Inc.2002-08-23
WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 (K012329)Wiener Laboratories Saic2001-09-21
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER (K011720)Olympus America, Inc.2001-06-25
CHEMWELL, MODEL 2900 (K010877)Awareness Technology, Inc.2001-05-23
ALBUMIN (K003327)Jas Diagnostics, Inc.2000-12-05
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (K992399)Bayer Corp.1999-09-15
ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM (K991576)Bayer Corp.1999-06-30
RANDOX ALBUMIN (K984494)Randox Laboratories, Ltd.1999-03-23
ALBG (K981758)Abbott Laboratories1998-06-12
ALBG (K981468)Abbott Laboratories1998-05-27
CARESIDE ALBUMIN (K980041)Exigent Diagnostics, Inc.1998-02-04
ALB OR ALBUMIN (K971445)Carolina Liquid Chemistries Corp.1997-05-02
ALBUMIN (K955781)Derma Media Lab., Inc.1996-03-13
TRACE COBAS MIRA RANGE (K952488)Trace Scientific , Ltd.1995-10-13
DMA ALBUMIN PROCEDURE (K946355)Data Medical Associates, Inc.1995-03-01
ALBUMIN QVET (K943000)Prisma Systems1994-12-13
EMDS ALBUMIN (ALB) TEST (K935179)Em Diagnostic Systems, Inc.1993-12-17
OLYMPUS ALBUMIN REAGENT (K924368)Olympus Corp.1993-02-08
ALBUMIN TEST (K923959)Em Diagnostic Systems, Inc.1992-12-28
TRACE ALBUMIN-MR REAGENT (K923322)Trace Scientific , Ltd.1992-09-11
OLYMPUS ALBUMIN REAGENT (K922369)Olympus Corp.1992-07-17
TECHNICON CHEM 1(TM) SYST (GEN2 SYST) (K914888)Technicon Instruments Corp.1991-11-27
ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37 (K913920)Em Diagnostic Systems, Inc.1991-09-27
KODAK EKTACHEM DT SLIDES (ALB) (K913195)Eastman Kodak Company1991-08-26
SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401 (K905660)Em Diagnostic Systems, Inc.1991-01-25
SYNERMED ALBUMIN REAGENT KIT (K903543)Synermed, Inc.1990-10-12
COULTER ALBUMIN REAGENT (K901268)Coulter Corp.1990-05-30
COBAS READY ALBUMIN REAGENT (K896235)Roche Diagnostic Systems, Inc.1990-02-27
CLINISTAT ALBUMIN REAGENT TEST (K896910)Miles Diagnostics Div.1990-01-18
ALBUMIN TEST (ALB) ITEM NUMBER: 65401 (K893777)Em Diagnostic Systems, Inc.1989-08-21
IQ ALBUMIN (K891375)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-05-05
BIOTROL ALBUMIN (K885094)Biotrol, USA, Inc.1989-02-10
ALBUMIN TEST (ALB) ITEM #65650 (K884705)Em Diagnostic Systems, Inc.1989-01-11
A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM (K882587)A-Kem, Inc.1988-08-08
ALBUMIN CAT. # 201-03 (K875207)Diagnostic Chemicals, Ltd. (Usa)1988-04-18
ALBUMIN REAGENT SET (K880844)Tech-Neal Scientific, Inc.1988-04-05
WAKO(TM) AUTOKIT ALBUMIN (K880313)Wako Chemicals USA, Inc.1988-03-24
ALBUMIN, BROMCRESOL GREEN DYE-BINDING (K875070)Tech-Co, Inc.1988-01-11
ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS (K874163)Catachem, Inc.1987-11-23
MULTICHEM ALBUMIN REAGENT S0902 (K874049)Simmler, Inc.1987-10-29
EASY-TEST ALBUMIN (ALB), ITEM NO. 19039 (K873994)Em Diagnostic Systems, Inc.1987-10-29
ALBUMIN REAGENT - BROMCRESOL GREEN METHOD (K870372)Trace Scientific , Ltd.1987-08-19
EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93 (K864715)Em Diagnostic Systems, Inc.1986-12-31
ALBUMIN PROCEDURE (K863263)Data Medical Associates, Inc.1986-09-15
ALBUMETER (K863050)J. D. Assoc.1986-09-11
ALBUMIN PROCEDURE (K861654)Data Medical Associates, Inc.1986-06-13
ALBUMIN (BCG) REAGENT (K861467)Sigma Diagnostics, Inc.1986-05-23
SANDARE BCG ALBUMIN PROCEDURE (K860684)Sandare Chemical Co., Inc.1986-03-17
AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENT (K860661)Amresco, Inc.1986-03-14
SERUM ALBUMIN (BCG) REAGENT SET (K860340)Sterling Diagnostics, Inc.1986-02-19
ALBUMIN REAGENT KIT (K860213)Bio-Analytics Laboratories, Inc.1986-02-11
ALBUMIN REAGENT SET (K855158)Technostics Intl.1986-01-14
NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926 (K854718)Nobel Scientific Industries, Inc.1985-12-19
IN-VITRO TEST DETERMINATION OF ALBUMIN (K854181)Clinical Data, Inc.1985-11-25
TDX AMYLASE (K853978)Abbott Laboratories1985-10-15
ALBUMIN SR LIQUID STABLE REAGENT SET (K853868)Medical Analysis Systems, Inc.1985-09-30
ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE (K853049)Simmler, Inc.1985-08-02
ALBUMIN (K850931)Dilab, Inc.1985-06-26
ALB BCG REAGENT (K852007)Alpkem Corp.1985-05-30
ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S (K851308)Technicon Instruments Corp.1985-04-17
ALBUMIN REAGENT FOR DEMAND ANALYZER (K844330)Advanced Biomedical Methods, Inc.1985-01-03
ALBUMIN REAGENT SET (K843831)Livonia Diagnostics, Inc.1984-10-11
ALBUMIN ASSAY KIT (K843104)Diagnostic Chemicals, Ltd. (Usa)1984-09-07
SYSTEMATE ALBUMIN (K843108)Em Diagnostic Systems, Inc.1984-08-27
ALBUMIN REAGENT SET (K841063)Medical Specialties, Inc.1984-05-01
ALBUMIN REAGENT (K840782)American Dade1984-04-13
MCS ALBUMIN REAGENT (K840291)Medilab Corp.1984-03-30
ALBUMIN REAGENT CS-716 (K833699)Fisher Scientific Co., LLC1984-01-13
ALBUMIN REAGENT SET (K832747)Biorent Diagnostic, Inc.1983-10-14
ALBUMIN REAGENT (BCG (K831585)Reagents Applications, Inc.1983-06-16
FLOW-PAC ALBUMIN REAGENT (K830536)Amresco, Inc.1983-03-24
COBAS REAGENT FOR ALBUMIN (K823574)Hoffmann-La Roche, Inc.1983-01-07
COBAS STANDARDS FOR ALBUMIN (K823575)Hoffmann-La Roche, Inc.1983-01-07
PSI ALBUMIN REAGENT (K822471)Pointe Scientific, Inc.,1982-09-14
ULTRA CHEM ALB (K821880)Harleco Diagnostics1982-07-14
ALBUMIN REAGENT SET (K821193)Omega Medical Electronics1982-07-13
ALBUMIN REAGENT (K821225)Hi Chem, Inc.1982-05-21
ULTRACHEM ALB, ITEM #64970 (K813044)Harleco1981-11-10
KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB) (K812030)Eastman Kodak Company1981-08-03
ALBUMIN TEST (K811662)King Diagnostics, Inc.1981-06-25
AMES SERA-PAK ALBUMIN REAGENT KIT (K803237)Miles Laboratories, Inc.1981-01-09
CENTRIFICHEM ALBUMIN (K802436)Union Carbide Corp.1980-10-31
BCG REAGENT SERUM ALBUMIN W/TECHNICON (K802157)Panmed, Inc.1980-10-10
BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY (K801750)Beckman Instruments, Inc.1980-09-16
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