# Genetic Testing Institute

- Location (FDA's records): Waukesha, WI
- FDA decisions: 6 (1984–2008): 6 510(k) clearances
- Product codes: LCO (3), GGP (2), DGX (1)
- Predicates its devices cite: 3 (3 its own); citations of its devices by later devices: 9 (3 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Immucor Gti Diagnostics, Inc.: 2 (https://510kreport.com/company/immucor-gti-diagnostics)
- Hyphen Biomed: 1 (https://510kreport.com/company/hyphen-biomed)
- Akers Biosciences, Inc.: 1 (https://510kreport.com/company/akers-biosciences)
- Precision Biologic: 1 (https://510kreport.com/company/precision-biologic)
- Akers Laboratories, Inc.: 1 (https://510kreport.com/company/akers-laboratories)

## Its most-cited devices
- K053559: PF4 Enhanced Solid Phase Elisa (2006), cited by 3
- K983379: Gti-PF4 Elisa (1999), cited by 3
- K082205: Factor Viii Antibody Screen (2008), cited by 1
- K071781: PF4 IGG (2007), cited by 1
- K993553: Gti-Fviii Inhibitor Assay (2000), cited by 1

## Recent decisions
- K082205: Factor Viii Antibody Screen (Nov 20, 2008)
- K071781: PF4 IGG (Dec 19, 2007)
- K053559: PF4 Enhanced Solid Phase Elisa (Jan 20, 2006)
- K993553: Gti-Fviii Inhibitor Assay (Feb 1, 2000)
- K983379: Gti-PF4 Elisa (Mar 9, 1999)
- K841114: Allo-Type Human Immunoglobulin- (Jun 14, 1984)

Source page: https://510kreport.com/company/genetic-testing-institute