FDA.reportPublic FDA data

510(k) K862138

Device
Vision Albumin
Applicant
ABBOTT LABORATORIES
510(k) number
K862138
Product code
CJW
Decision
Substantially Equivalent (SESE)
Decision date
1986-06-17
Date received
1986-06-04
Regulation
862.1035
Classification name
Bromcresol Purple Dye-Binding, Albumin
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MATT KLAMRZYNSKI
Address
One Abbott Park Rd. Abbott Park IL US 60064 60064

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
K860423A-GENT LIQUID ALBUMINAbbott Laboratories1986-03-17
K844426ALBUMIN BCPBoehringer Mannheim Corp.1985-01-07
K842847WAKO AUTOMATED REAGENTS FOR HITACHI 705Wako Chemicals USA, Inc.1984-12-11