MSJ — Apolipoproteins Class I

FDA Device Classification

Classification Details

Product Code
MSJ
Device Class
Class I
Regulation Number
862.1475
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K072977general atomicsDIAZYME APOLIPOPROTEIN A-1 ASSAYJuly 16, 2008
K073488diazyme laboratoriesDIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXXMarch 7, 2008
K061377pointe scientific, incAPOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORSMarch 28, 2007
K063608dade behringDIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR February 23, 2007
K992662bayer8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMFebruary 15, 2000
K970314beckman instrumentsSYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTSApril 21, 1997
K964010beckman instrumentsIMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEFebruary 10, 1997
K931777nichols instituteAPO A-1 CHEMILUMINESCENCE ASSAYAugust 16, 1993
K925702nichols institute diagnosticsNICHOLS APO B CHEMILUMINESCENCE ASSAYDecember 23, 1992
K923087instrumentation laboratoryIL TEST APOLIPOPROTEIN A1October 26, 1992
K923080instrumentation laboratoryIL TEST APOLIPOROTEIN B (APO B)October 26, 1992
K921795bacton assay systemsBACTON(TM), AUTO-APO A-1 REAGENTJune 23, 1992
K921862bacton assay systemsBACTON(TM), AUTO-APO B REAGENTJune 22, 1992
K921037baxter diagnosticsAPOLIPOPROTEIN TEST SYSTEMMay 22, 1992
K914069medical analysis systemsREFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1October 2, 1991
K912749medical analysis systemsREFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN BSeptember 23, 1991
K910551roche diagnostic systemsROCHE REAGENT FOR APOLIPOPROTEIN A-1May 7, 1991
K910552roche diagnostic systemsROCHE REAGENT FOR APOLIPOPROTEIN BMay 7, 1991
K895277medical marketing consultantsORTHO APO B ELISA TEST SYSTEMSeptember 27, 1989
K893884catachemBACTON TM, BASIC TM, APO B REAGENTJune 21, 1989