# GGW: Test, Time, Partial Thromboplastin

- Device class: 2; regulation: 21 CFR 864.7925; FDA's rule: 510(k) required
- FDA decisions: 32
- Recalls: 3 (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)
- 1992: 2
- 1993: 1
- 1995: 2
- 1996: 1
- 1999: 2
- 2004: 2
- 2006: 1
- 2009: 1
- 2010: 1
- 2026: 1

## Most-cited predicates
- K963111: Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V S (1996), cited by 5
- K945940: Coatest (R) Apc (TM) Resistance (1995), cited by 1
- K863594: Actin FSL Activated PTT Reagent (1986), cited by 1
- K873382: Platelet Extract Reagent (1987), cited by 1
- K792048: Lancer Coagent Aptt Kit (1979), cited by 1
- K992456: Gradileiden V Test (1999), cited by 1

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