# CKE: Acid Phosphatase, Thymolphthale Inmonophosphate

- Device class: 2; regulation: 21 CFR 862.1020; FDA's rule: 510(k) exempt
- FDA decisions: 9
- 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)
- 1979: 1
- 1980: 1
- 1982: 1
- 1984: 1
- 1986: 2
- 1988: 1
- 1992: 2

## Most-cited predicates
- K864230: Dimension (TM) Clinical Chemistry System (1986), cited by 1

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