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510(k) K921037

Device
APOLIPOPROTEIN TEST SYSTEM
Applicant
BAXTER DIAGNOSTICS, INC.
510(k) number
K921037
Product code
MSJ  
Decision
Substantially Equivalent (SESE)
Decision date
1992-05-22
Date received
1992-03-04
Regulation
862.1475
Classification name
Apolipoproteins
Medical specialty
Clinical Chemistry
Review panel
Immunology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SCOTT BEGGINS
Address
P.O. Box 25101 Santa Ana CA US 92799 92799

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MSJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K072977DIAZYME APOLIPOPROTEIN A-1 ASSAYGeneral Atomics2008-07-16
K073488DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXXDiazyme Laboratories2008-03-07
K061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORSPointe Scientific, Inc.,2007-03-28
K063608DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGHDade Behring, Inc.2007-02-23
K9926628 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMBayer Corp.2000-02-15
K970314SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTSBeckman Instruments, Inc.1997-04-21
K964010IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENTBeckman Instruments, Inc.1997-02-10
K931777APO A-1 CHEMILUMINESCENCE ASSAYNichols Institute1993-08-16
K925702NICHOLS APO B CHEMILUMINESCENCE ASSAYNichols Institute Diagnostics1992-12-23
K923087IL TEST APOLIPOPROTEIN A1Instrumentation Laboratory CO1992-10-26
K923080IL TEST APOLIPOROTEIN B (APO B)Instrumentation Laboratory CO1992-10-26
K921795BACTON(TM), AUTO-APO A-1 REAGENTBacton Assay Systems, Inc.1992-06-23
K921862BACTON(TM), AUTO-APO B REAGENTBacton Assay Systems, Inc.1992-06-22
K914069REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1Medical Analysis Systems, Inc.1991-10-02
K912749REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN BMedical Analysis Systems, Inc.1991-09-23

Legacy Summary#

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FDA Review#

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