# CDP: Radioimmunoassay, Total Triiodothyronine

- Device class: 2; regulation: 21 CFR 862.1710; FDA's rule: 510(k) exempt
- FDA decisions: 144
- Recalls: 10 (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)
- 1991: 5
- 1992: 7
- 1993: 4
- 1994: 5
- 1995: 1
- 1996: 14
- 1997: 5
- 1998: 5
- 1999: 3
- 2000: 1

## Most-cited predicates
- K934517: Axsym Total T3 (1994), cited by 1
- K953160: OPUS T3 (1995), cited by 1
- K983439: Abbott Architect Free T3 (1998), cited by 1
- K932747: Ciba Corning Acs Free T3 Immunoassay (1993), cited by 1
- K970016: Vitros Immunodiagnositcs Products-Free T3 Reagent Pack (Gem.1020)/Free T3 Calibrators (Gem.C020) (1997), cited by 1

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