# JOZ: System, Automated Platelet Aggregation

- Device class: 2; regulation: 21 CFR 864.5700; FDA's rule: 510(k) required
- FDA decisions: 38
- Recalls: 6 (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)
- 2004: 3
- 2005: 2
- 2006: 1
- 2012: 1
- 2013: 1
- 2015: 2
- 2016: 1
- 2017: 1
- 2019: 1
- 2020: 1

## Most-cited predicates
- K042423: Verifynow-Aspirin Assay (2004), cited by 2
- K050265: Chrono-Log Whole Blood Lumi-Aggregometer, Model 700 (2005), cited by 2
- K041502: Thrombelastograph (Teg) Platelet Mapping Assay (2004), cited by 1
- K954997: Centocor Aggrestat, Collagen Reagent, Control Reagent (1996), cited by 1
- K060489: Dade Pfa-100 Platelet Function Analyzer and Reagents (2006), cited by 1
- K051231: Verifynow-P2Y12 Assay (2005), cited by 1
- K970505: Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa Collagen/Adp Test Cartridge/ (1997), cited by 1
- K032951: Chrono-Log Whole Blood Aggregometer, Models 591A and 592A (2004), cited by 1
- K962426: Chrono-Log Whole Blood Aggregometer (Wba) 591/592 (1996), cited by 1
- K141427: Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow Prutest (2015), cited by 1

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