# JMM: Column Chromatography & Color Development, Hydroxyproline

- Device class: 1; regulation: 21 CFR 862.1400; FDA's rule: 510(k) exempt
- FDA decisions: 21
- 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)
- 1977: 1
- 1995: 4
- 1996: 3
- 1997: 2
- 1998: 5
- 1999: 4
- 2000: 1
- 2001: 1

## Most-cited predicates
- K974260: Pyrilinks-D Assay Kit (1998), cited by 1
- K960171: Active Crosslaps Elisa (1996), cited by 1
- K980518: Osteomark (1998), cited by 1
- K952320: Pyrilinks-D Assay Kit (1995), cited by 1
- K990843: Serum Crosslaps One Step Elisa (1999), cited by 1
- K972788: Crosslaps Elisa (1998), cited by 1
- K993706: Elecsys Serum B-Crosslaps/Serum Immunoassay (2000), cited by 1

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