Atlas FDA

MSJ

50 FDA 510(k) clearances · Product code

71 daysmedian time to decision
190 days90th percentile
50clearances measured

FDA profile

Official device name
Apolipoproteins
Device class
Class I (low risk)
Regulation
21 CFR 862.1475
Medical specialty
Clinical Chemistry
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RecordFirmDate
DIAZYME APOLIPOPROTEIN A-1 ASSAY (K072977)General Atomics2008-07-16
DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX (K073488)Diazyme Laboratories2008-03-07
APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS (K061377)Pointe Scientific, Inc.,2007-03-28
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH (K063608)Dade Behring, Inc.2007-02-23
8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM (K992662)Bayer Corp.2000-02-15
SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS (K970314)Beckman Instruments, Inc.1997-04-21
IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT (K964010)Beckman Instruments, Inc.1997-02-10
APO A-1 CHEMILUMINESCENCE ASSAY (K931777)Nichols Institute1993-08-16
NICHOLS APO B CHEMILUMINESCENCE ASSAY (K925702)Nichols Institute Diagnostics1992-12-23
IL TEST APOLIPOPROTEIN A1 (K923087)Instrumentation Laboratory CO1992-10-26
IL TEST APOLIPOROTEIN B (APO B) (K923080)Instrumentation Laboratory CO1992-10-26
BACTON(TM), AUTO-APO A-1 REAGENT (K921795)Bacton Assay Systems, Inc.1992-06-23
BACTON(TM), AUTO-APO B REAGENT (K921862)Bacton Assay Systems, Inc.1992-06-22
APOLIPOPROTEIN TEST SYSTEM (K921037)Baxter Diagnostics, Inc.1992-05-22
REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1 (K914069)Medical Analysis Systems, Inc.1991-10-02
REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B (K912749)Medical Analysis Systems, Inc.1991-09-23
ROCHE REAGENT FOR APOLIPOPROTEIN B (K910552)Roche Diagnostic Systems, Inc.1991-05-07
ROCHE REAGENT FOR APOLIPOPROTEIN A-1 (K910551)Roche Diagnostic Systems, Inc.1991-05-07
ORTHO APO B ELISA TEST SYSTEM (K895277)Medical Marketing Consultants, Inc.1989-09-27
BACTON TM, BASIC TM, APO B REAGENT (K893884)Catachem, Inc.1989-06-21
SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B (K891154)Atlantic Antibodies1989-03-16
QM300 APOLIPOPROTEIN B ANTIBODY PACK (K883714)Kallestad Diag, A Div. of Erbamont, Inc.1988-10-19
QM300 APOLIPOPROTEIN A-I ANTIBODY PACK (K883713)Kallestad Diag, A Div. of Erbamont, Inc.1988-10-19
TECHNICON DPA-1 APOLIPOPROTEIN B (K883491)Technicon Instruments Corp.1988-09-07
APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM (K882620)Technicon Instruments Corp.1988-07-08
MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B (K881898)Atlantic Antibodies1988-06-14
HEART CHECK APOLIPOPROTEIN-B (K881433)Northwest Biotech1988-04-21
HEART CHECK APOLIPOPROTEIN A-1 (K881434)Northwest Biotech1988-04-21
APOLIPOPROTEIN B (K873864)Unipath , Ltd.1987-10-13
APOLIPOPROTEIN A1 (K873863)Unipath , Ltd.1987-10-13
MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT (K872794)Medix Biotech, Inc.1987-09-23
RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS (K872079)Reagents Applications, Inc.1987-06-15
SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B (K870564)Atlantic Antibodies1987-03-24
SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL (K870862)Atlantic Antibodies1987-03-24
APO B., IMMUNOTURBIDIMETRIC ASSAY (K864228)Intl. Diagnostic Laboratories, Ltd.1987-03-12
APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC (K864393)Intl. Diagnostic Laboratories, Ltd.1987-01-16
IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1 (K861883)Orion Corp.1986-10-29
IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B (K861882)Orion Corp.1986-10-29
ICS APOLIPOPROTEIN A-1 REAGENT TEST KIT (K862019)Beckman Instruments, Inc.1986-07-18
ICS APOLIPOPROTEIN B REAGENT TEST KIT (K862386)Beckman Instruments, Inc.1986-07-18
VENTREX APO B (K861919)Ventrex Laboratories, Inc.1986-06-06
BIOGRAM APO A1/B (K860629)Bio-Rad1986-03-28
ANTISERUM TO HUMAN APOLIPOPROTEIN B (K850690)Kent Laboratories, Inc.1985-11-01
ANTISERUM TO HUMAN APOLIPOPROTEIN A-I (K850691)Kent Laboratories, Inc.1985-11-01
APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN (K853174)Photec Diagnostics, Inc.1985-08-22
THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL (K851641)Ortho Diagnostic Systems, Inc.1985-07-23
APO B RIA KIT (K851389)Iso-Tex Diagnostics1985-07-10
LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS (K850638)Behring Diagnostics, Inc.1985-05-15
DIFFU-GEN APOLIPOPROTEIN A-I RADIAL - (K834218)Tago, Inc.1984-05-11
TAGO DIFFU-GEN-APOLIPOPROTEIN B-100 (K833129)Tago, Inc.1983-11-21

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