# JLB: Atp And Creatine Kinase (Enzymatic), Creatine

- Device class: 1; regulation: 21 CFR 862.1210; FDA's rule: 510(k) exempt
- FDA decisions: 3
- Recalls: 2 (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
- 1997: 1
- 1999: 1

## Most-cited predicates
- K782156: Unitest Creatine Kinase (1979), cited by 1
- K992140: Piccolo Metlyte 7 Reagent Disc (1999), cited by 1
- K971817: Olympus CK-MB Reagent (1997), cited by 1

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