FDA.reportPublic FDA data

510(k) K132664

Device
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
510(k) number
K132664
Product code
CJW  
Decision
Substantially Equivalent (SESE)
Decision date
2013-10-16
Date received
2013-08-27
Regulation
862.1035
Classification name
Bromcresol Purple Dye-binding, Albumin
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KIRA GORDON
Address
511 Benedict Ave. Tarrytown NY US 10591 10591

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K842847WAKO AUTOMATED REAGENTS FOR HITACHI 705Wako Chemicals USA, Inc.1984-12-11

Legacy Summary#

summary

FDA Review#

Decision Summary