Product code CIX— Clinical Chemistry
ALBUMIN REAGENT SET
- Classification name
- Bromcresol Green Dye-Binding, Albumin
- Device class
- Class 2
- Regulation
- 21 CFR 862.1035
- Advisory panel
- Clinical Chemistry
- Total cleared
- 120
- First cleared
- Most recent
Market context for product code CIX
FDA has cleared devices under product code CIX between 1976 and 2026, filed by 87 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2021
- 2019
- 2018
- 2013
- 2012
- 2011
- 2009
- 2008
- 2007
- 2003
- 2002
- 2001
- 2000
- 1999
Top applicants under product code CIX
Recent clearances under product code CIX
1–100 of 120- K251157 — Core Metabolic
- K203248 — Albumin BCG2
- K200898 — Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
- K191316 — VITROS XT Chemistry Products ALB-TP Slides
- K170901 — ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400
- K131488 — ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT
- K113374 — ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT
- K110818 — POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS
- K110830 — ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2
- K101088 — EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT
- K080874 — EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT
- K072143 — S40 CLINICAL ANALYZER, S TEST ALB
- K060434 — ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL
- K033009 — ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
- K030006 — ATAC PAK ALBUMIN REAGENT
- K023875 — VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4
- K022072 — PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS
- K012329 — WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300
- K011720 — OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
- K010877 — CHEMWELL, MODEL 2900
- K003327 — ALBUMIN
- K992399 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
- K991576 — ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
- K984494 — RANDOX ALBUMIN
- K981758 — ALBG
- K981468 — ALBG
- K980041 — CARESIDE ALBUMIN
- K971445 — ALB OR ALBUMIN
- K955781 — ALBUMIN
- K952488 — TRACE COBAS MIRA RANGE
- K946355 — DMA ALBUMIN PROCEDURE
- K943000 — ALBUMIN QVET
- K935179 — EMDS ALBUMIN (ALB) TEST
- K924368 — OLYMPUS ALBUMIN REAGENT
- K923959 — ALBUMIN TEST
- K923322 — TRACE ALBUMIN-MR REAGENT
- K922369 — OLYMPUS ALBUMIN REAGENT
- K914888 — TECHNICON CHEM 1(TM) SYST (GEN2 SYST)
- K913920 — ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37
- K913195 — KODAK EKTACHEM DT SLIDES (ALB)
- K905660 — SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401
- K903543 — SYNERMED ALBUMIN REAGENT KIT
- K901268 — COULTER ALBUMIN REAGENT
- K896235 — COBAS READY ALBUMIN REAGENT
- K896910 — CLINISTAT ALBUMIN REAGENT TEST
- K893777 — ALBUMIN TEST (ALB) ITEM NUMBER: 65401
- K891375 — IQ ALBUMIN
- K885094 — BIOTROL ALBUMIN
- K884705 — ALBUMIN TEST (ALB) ITEM #65650
- K882587 — A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM
- K875207 — ALBUMIN CAT. # 201-03
- K880844 — ALBUMIN REAGENT SET
- K880313 — WAKO(TM) AUTOKIT ALBUMIN
- K875070 — ALBUMIN, BROMCRESOL GREEN DYE-BINDING
- K874163 — ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS
- K873994 — EASY-TEST ALBUMIN (ALB), ITEM NO. 19039
- K874049 — MULTICHEM ALBUMIN REAGENT S0902
- K870372 — ALBUMIN REAGENT - BROMCRESOL GREEN METHOD
- K864715 — EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93
- K863263 — ALBUMIN PROCEDURE
- K863050 — ALBUMETER
- K861654 — ALBUMIN PROCEDURE
- K861467 — ALBUMIN (BCG) REAGENT
- K860684 — SANDARE BCG ALBUMIN PROCEDURE
- K860661 — AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENT
- K860340 — SERUM ALBUMIN (BCG) REAGENT SET
- K860213 — ALBUMIN REAGENT KIT
- K855158 — ALBUMIN REAGENT SET
- K854718 — NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926
- K854181 — IN-VITRO TEST DETERMINATION OF ALBUMIN
- K853978 — TDX AMYLASE
- K853868 — ALBUMIN SR LIQUID STABLE REAGENT SET
- K853049 — ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE
- K850931 — ALBUMIN
- K852007 — ALB BCG REAGENT
- K851308 — ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S
- K844330 — ALBUMIN REAGENT FOR DEMAND ANALYZER
- K843831 — ALBUMIN REAGENT SET
- K843104 — ALBUMIN ASSAY KIT
- K843108 — SYSTEMATE ALBUMIN
- K841063 — ALBUMIN REAGENT SET
- K840782 — ALBUMIN REAGENT
- K840291 — MCS ALBUMIN REAGENT
- K833699 — ALBUMIN REAGENT CS-716
- K832747 — ALBUMIN REAGENT SET
- K831585 — ALBUMIN REAGENT (BCG
- K830536 — FLOW-PAC ALBUMIN REAGENT
- K823574 — COBAS REAGENT FOR ALBUMIN
- K823575 — COBAS STANDARDS FOR ALBUMIN
- K822471 — PSI ALBUMIN REAGENT
- K821880 — ULTRA CHEM ALB
- K821193 — ALBUMIN REAGENT SET
- K821225 — ALBUMIN REAGENT
- K813044 — ULTRACHEM ALB, ITEM #64970
- K812030 — KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB)
- K811662 — ALBUMIN TEST
- K803237 — AMES SERA-PAK ALBUMIN REAGENT KIT
- K802436 — CENTRIFICHEM ALBUMIN
- K802157 — BCG REAGENT SERUM ALBUMIN W/TECHNICON
- K801750 — BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY
Data sourced from openFDA. This site is unofficial and independent of the FDA.