# CKB: Acid Phosphatase, Naphthyl Phosphate

- Device class: 2; regulation: 21 CFR 862.1020; FDA's rule: 510(k) exempt
- FDA decisions: 24
- Recalls: 1 (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)
- 1986: 3
- 1988: 3
- 1989: 2
- 1990: 2
- 1996: 1
- 1997: 1
- 1998: 2
- 1999: 1
- 2003: 1
- 2006: 1

## Most-cited predicates
- K981743: Olympus AU400 Clinical Chemistry Analyzer (1998), cited by 2
- K023840: Acid Phosphatase Assay for the Advia 1650 (2003), cited by 2
- K821674: Spinchem Acid Phosphatase Reagent (1982), cited by 1
- K831834: Raichem Acid Phasphatase Reagent (1983), cited by 1
- K943366: IL Test Acid Phosphatase (1996), cited by 1
- K880798: Acid Phosphatase Reagent (1988), cited by 1

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