# MSJ: Apolipoproteins

- Device class: 1; regulation: 21 CFR 862.1475; FDA's rule: 510(k) exempt
- FDA decisions: 50
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1987: 8
- 1988: 7
- 1989: 3
- 1991: 4
- 1992: 6
- 1993: 1
- 1997: 2
- 2000: 1
- 2007: 2
- 2008: 2

## Most-cited predicates
- K862019: Ics Apolipoprotein a-1 Reagent Test Kit (1986), cited by 2
- K862386: Ics Apolipoprotein B Reagent Test Kit (1986), cited by 2
- K063608: Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and Control Medium and High (2007), cited by 1
- K910552: Roche Reagent for Apolipoprotein B (1991), cited by 1
- K870564: SPQ (TM) Test System for Apolipoprotein B (1987), cited by 1
- K992662: 8 Additional Assays for the Bayer Advia 1650 Chemistry System (2000), cited by 1

Source page: https://510kreport.com/product-code/MSJ
Data by year (CSV): https://510kreport.com/product-code/MSJ.csv