FDA 510(k) Applications for Medical Device Product Code "CJW"
(Bromcresol Purple Dye-Binding, Albumin)

FDA 510(k) Number Applicant Device Name Decision Date
K990978 A.P. TOTAL CARE, INC. ALBUMIN BCG, MODEL AL 103-01 05/25/1999
K860423 ABBOTT LABORATORIES A-GENT LIQUID ALBUMIN 03/17/1986
K981814 ABBOTT LABORATORIES ALBP 07/22/1998
K862138 ABBOTT LABORATORIES VISION ALBUMIN 06/17/1986
K981457 ABBOTT MFG., INC. ALBP 05/27/1998
K905776 BIOCHEMICAL TRADE, INC. ALBUMIN REAGENT SET 02/26/1991
K844426 BOEHRINGER MANNHEIM CORP. ALBUMIN BCP 01/07/1985
K913025 EM DIAGNOSTIC SYSTEMS, INC. ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 10/09/1991
K863004 EM DIAGNOSTIC SYSTEMS, INC. EMDS(TM) ALBUMIN TESTPACKS, #67652/95 09/16/1986
K021636 INTERSECT SYSTEMS, INC. ALBUMIN REAGENT 07/17/2002
K830934 QUANTIMETRIX CORP. QUANTIMETRIX BROMERESOL PURPLE ALBUMIN 04/18/1983
K000483 RANDOX LABORATORIES, LTD. RANDOX ALBUMIN 03/31/2000
K832632 SANDARE CHEMICAL CO., INC. ALBUMIN PROCEDURE BCP 09/12/1983
K132664 SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR 10/16/2013
K863226 SIGMA DIAGNOSTICS, INC. ALBUMIN (BCP) 09/17/1986
K842847 WAKO CHEMICALS, USA, INC. WAKO AUTOMATED REAGENTS FOR HITACHI 705 12/11/1984


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