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510(k) K830934

Device
QUANTIMETRIX BROMERESOL PURPLE ALBUMIN
Applicant
QUANTIMETRIX CORP.
510(k) number
K830934
Product code
CJW  
Decision
Substantially Equivalent (SESE)
Decision date
1983-04-18
Date received
1983-03-23
Regulation
862.1035
Classification name
Bromcresol Purple Dye-binding, Albumin
Medical specialty
Clinical Chemistry
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CJW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K203530Albumin BCP2Abbott Ireland Diagnostics Division2022-03-18
K193001Albumin BCPSENTINEL CH. SpA2019-12-19
K132664ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATORSiemens Healthcare Diagnostics, Inc.2013-10-16
K021636ALBUMIN REAGENTIntersect Systems, Inc.2002-07-17
K000483RANDOX ALBUMINRandox Laboratories, Ltd.2000-03-31
K990978ALBUMIN BCG, MODEL AL 103-01A.P. Total Care, Inc.1999-05-25
K981814ALBPAbbott Laboratories1998-07-22
K981457ALBPAbbott Mfg., Inc.1998-05-27
K913025ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16Em Diagnostic Systems, Inc.1991-10-09
K905776ALBUMIN REAGENT SETBiochemical Trade, Inc.1991-02-26
K863226ALBUMIN (BCP)Sigma Diagnostics, Inc.1986-09-17
K863004EMDS(TM) ALBUMIN TESTPACKS, #67652/95Em Diagnostic Systems, Inc.1986-09-16
K862138VISION ALBUMINAbbott Laboratories1986-06-17
K860423A-GENT LIQUID ALBUMINAbbott Laboratories1986-03-17
K844426ALBUMIN BCPBoehringer Mannheim Corp.1985-01-07

Legacy Summary#

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FDA Review#

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