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Apolipoproteins

FDA product code MSJ · 50 cleared devices

Class 1 Clinical Chemistry

Regulation: 21 CFR 862.1475
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1983-11-21 – 2008-07-16

MSJ 2008-07-16

DIAZYME APOLIPOPROTEIN A-1 ASSAY

Applicant General Atomics

K number K072977

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MSJ 2008-03-07

DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX

Applicant Diazyme Laboratories

K number K073488

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MSJ 2007-03-28

APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS

Applicant Pointe Scientific, Inc.,

K number K061377

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MSJ 2007-02-23

DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH

Applicant Dade Behring, Inc.

K number K063608

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MSJ 2000-02-15

8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM

Applicant Bayer Corp.

K number K992662

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MSJ 1997-04-21

SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS

Applicant Beckman Instruments, Inc.

K number K970314

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MSJ 1997-02-10

IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT

Applicant Beckman Instruments, Inc.

K number K964010

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MSJ 1993-08-16

APO A-1 CHEMILUMINESCENCE ASSAY

Applicant Nichols Institute

K number K931777

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MSJ 1992-12-23

NICHOLS APO B CHEMILUMINESCENCE ASSAY

Applicant Nichols Institute Diagnostics

K number K925702

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MSJ 1992-10-26

IL TEST APOLIPOPROTEIN A1

Applicant Instrumentation Laboratory CO

K number K923087

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MSJ 1992-10-26

IL TEST APOLIPOROTEIN B (APO B)

Applicant Instrumentation Laboratory CO

K number K923080

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MSJ 1992-06-23

BACTON(TM), AUTO-APO A-1 REAGENT

Applicant Bacton Assay Systems, Inc.

K number K921795

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MSJ 1992-06-22

BACTON(TM), AUTO-APO B REAGENT

Applicant Bacton Assay Systems, Inc.

K number K921862

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MSJ 1992-05-22

APOLIPOPROTEIN TEST SYSTEM

Applicant Baxter Diagnostics, Inc.

K number K921037

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MSJ 1991-10-02

REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1

Applicant Medical Analysis Systems, Inc.

K number K914069

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MSJ 1991-09-23

REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B

Applicant Medical Analysis Systems, Inc.

K number K912749

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MSJ 1991-05-07

ROCHE REAGENT FOR APOLIPOPROTEIN B

Applicant Roche Diagnostic Systems, Inc.

K number K910552

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MSJ 1991-05-07

ROCHE REAGENT FOR APOLIPOPROTEIN A-1

Applicant Roche Diagnostic Systems, Inc.

K number K910551

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MSJ 1989-09-27

ORTHO APO B ELISA TEST SYSTEM

Applicant Medical Marketing Consultants, Inc.

K number K895277

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MSJ 1989-06-21

BACTON TM, BASIC TM, APO B REAGENT

Applicant Catachem, Inc.

K number K893884

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MSJ 1989-03-16

SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B

Applicant Atlantic Antibodies

K number K891154

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MSJ 1988-10-19

QM300 APOLIPOPROTEIN B ANTIBODY PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K883714

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MSJ 1988-10-19

QM300 APOLIPOPROTEIN A-I ANTIBODY PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K883713

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MSJ 1988-09-07

TECHNICON DPA-1 APOLIPOPROTEIN B

Applicant Technicon Instruments Corp.

K number K883491

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MSJ 1988-07-08

APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM

Applicant Technicon Instruments Corp.

K number K882620

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MSJ 1988-06-14

MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B

Applicant Atlantic Antibodies

K number K881898

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MSJ 1988-04-21

HEART CHECK APOLIPOPROTEIN A-1

Applicant Northwest Biotech

K number K881434

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MSJ 1988-04-21

HEART CHECK APOLIPOPROTEIN-B

Applicant Northwest Biotech

K number K881433

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MSJ 1987-10-13

APOLIPOPROTEIN B

Applicant Unipath , Ltd.

K number K873864

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MSJ 1987-10-13

APOLIPOPROTEIN A1

Applicant Unipath , Ltd.

K number K873863

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MSJ 1987-09-23

MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT

Applicant Medix Biotech, Inc.

K number K872794

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MSJ 1987-06-15

RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS

Applicant Reagents Applications, Inc.

K number K872079

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MSJ 1987-03-24

SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL

Applicant Atlantic Antibodies

K number K870862

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MSJ 1987-03-24

SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B

Applicant Atlantic Antibodies

K number K870564

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MSJ 1987-03-12

APO B., IMMUNOTURBIDIMETRIC ASSAY

Applicant Intl. Diagnostic Laboratories, Ltd.

K number K864228

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MSJ 1987-01-16

APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC

Applicant Intl. Diagnostic Laboratories, Ltd.

K number K864393

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MSJ 1986-10-29

IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1

Applicant Orion Corp.

K number K861883

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MSJ 1986-10-29

IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B

Applicant Orion Corp.

K number K861882

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MSJ 1986-07-18

ICS APOLIPOPROTEIN B REAGENT TEST KIT

Applicant Beckman Instruments, Inc.

K number K862386

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MSJ 1986-07-18

ICS APOLIPOPROTEIN A-1 REAGENT TEST KIT

Applicant Beckman Instruments, Inc.

K number K862019

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MSJ 1986-06-06

VENTREX APO B

Applicant Ventrex Laboratories, Inc.

K number K861919

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MSJ 1986-03-28

BIOGRAM APO A1/B

Applicant Bio-Rad

K number K860629

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MSJ 1985-11-01

ANTISERUM TO HUMAN APOLIPOPROTEIN A-I

Applicant Kent Laboratories, Inc.

K number K850691

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MSJ 1985-11-01

ANTISERUM TO HUMAN APOLIPOPROTEIN B

Applicant Kent Laboratories, Inc.

K number K850690

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MSJ 1985-08-22

APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN

Applicant Photec Diagnostics, Inc.

K number K853174

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MSJ 1985-07-23

THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL

Applicant Ortho Diagnostic Systems, Inc.

K number K851641

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MSJ 1985-07-10

APO B RIA KIT

Applicant Iso-Tex Diagnostics

K number K851389

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MSJ 1985-05-15

LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS

Applicant Behring Diagnostics, Inc.

K number K850638

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MSJ 1984-05-11

DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -

Applicant Tago, Inc.

K number K834218

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MSJ 1983-11-21

TAGO DIFFU-GEN-APOLIPOPROTEIN B-100

Applicant Tago, Inc.

K number K833129

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