# CIN: Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

- Device class: 2; regulation: 21 CFR 862.1050; FDA's rule: 510(k) required
- FDA decisions: 26
- 510(k) review time 2021–2025: median 210 days (middle half 210–210)
- Recalls: 6 (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)
- 1995: 1
- 1996: 1
- 1997: 2
- 1998: 1
- 2000: 1
- 2001: 1
- 2002: 1
- 2005: 1
- 2020: 1
- 2024: 1

## Most-cited predicates
- K961573: Tandem-R Ostase Immunoradiometric Assay (1996), cited by 2
- K930810: Tandem-R Ostase Immunoradiometric Assay (1994), cited by 1
- K972666: Tandem-MP Ostase Immunoenzymetric Assay (1997), cited by 1
- K994278: Access Ostase Immunoenzymetric Assay (2000), cited by 1

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