Product code MSJ— Clinical Chemistry
8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
- Classification name
- Apolipoproteins
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Total cleared
- 50
- First cleared
- Most recent
Market context for product code MSJ
FDA has cleared devices under product code MSJ between 1983 and 2008, filed by 32 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2008
- 2007
- 2000
- 1997
- 1993
- 1992
- 1991
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
- 1983
Top applicants under product code MSJ
Recent clearances under product code MSJ
- K072977 — DIAZYME APOLIPOPROTEIN A-1 ASSAY
- K073488 — DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX
- K061377 — APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
- K063608 — DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
- K992662 — 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
- K970314 — SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
- K964010 — IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT
- K931777 — APO A-1 CHEMILUMINESCENCE ASSAY
- K925702 — NICHOLS APO B CHEMILUMINESCENCE ASSAY
- K923080 — IL TEST APOLIPOROTEIN B (APO B)
- K923087 — IL TEST APOLIPOPROTEIN A1
- K921795 — BACTON(TM), AUTO-APO A-1 REAGENT
- K921862 — BACTON(TM), AUTO-APO B REAGENT
- K921037 — APOLIPOPROTEIN TEST SYSTEM
- K914069 — REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1
- K912749 — REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B
- K910551 — ROCHE REAGENT FOR APOLIPOPROTEIN A-1
- K910552 — ROCHE REAGENT FOR APOLIPOPROTEIN B
- K895277 — ORTHO APO B ELISA TEST SYSTEM
- K893884 — BACTON TM, BASIC TM, APO B REAGENT
- K891154 — SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B
- K883713 — QM300 APOLIPOPROTEIN A-I ANTIBODY PACK
- K883714 — QM300 APOLIPOPROTEIN B ANTIBODY PACK
- K883491 — TECHNICON DPA-1 APOLIPOPROTEIN B
- K882620 — APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM
- K881898 — MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B
- K881433 — HEART CHECK APOLIPOPROTEIN-B
- K881434 — HEART CHECK APOLIPOPROTEIN A-1
- K873863 — APOLIPOPROTEIN A1
- K873864 — APOLIPOPROTEIN B
- K872794 — MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT
- K872079 — RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS
- K870564 — SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B
- K870862 — SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL
- K864228 — APO B., IMMUNOTURBIDIMETRIC ASSAY
- K864393 — APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC
- K861882 — IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B
- K861883 — IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1
- K862019 — ICS APOLIPOPROTEIN A-1 REAGENT TEST KIT
- K862386 — ICS APOLIPOPROTEIN B REAGENT TEST KIT
- K861919 — VENTREX APO B
- K860629 — BIOGRAM APO A1/B
- K850690 — ANTISERUM TO HUMAN APOLIPOPROTEIN B
- K850691 — ANTISERUM TO HUMAN APOLIPOPROTEIN A-I
- K853174 — APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN
- K851641 — THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL
- K851389 — APO B RIA KIT
- K850638 — LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS
- K834218 — DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -
- K833129 — TAGO DIFFU-GEN-APOLIPOPROTEIN B-100
Data sourced from openFDA. This site is unofficial and independent of the FDA.