# Autogenomics, Incorporated

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 4 (2007–2023): 3 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Autogenomics, Incorporated (2); AutoGenomics, Inc. (2)
- Product codes: NTI (1), NPQ (1), ODW (1), QZH (1)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 7 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Molecular Systems, Inc.: 2 (https://510kreport.com/company/roche-molecular-systems)

## Firms that cite its devices most
- Illumina, Inc.: 2 (https://510kreport.com/company/illumina)
- Spartan Bioscience, Inc.: 1 (https://510kreport.com/company/spartan-bioscience)
- Sequenom, Inc.: 1 (https://510kreport.com/company/sequenom)
- Nanosphere, Inc.: 1 (https://510kreport.com/company/nanosphere)

## Its most-cited devices
- K060564: Infiniti System (2007), cited by 4
- K101683: Infiniti CYP2C19 Assay (2010), cited by 2
- K073014: Infiniti 2C9 & VKORC1 Multiplex Assay for Warfarin (2008), cited by 1

## Recent decisions
- P230032: AvertD and AvertD Buccal Sample Collection Kit (Dec 19, 2023)
- K101683: Infiniti CYP2C19 Assay (Oct 25, 2010)
- K073014: Infiniti 2C9 & VKORC1 Multiplex Assay for Warfarin (Jan 23, 2008)
- K060564: Infiniti System (Feb 7, 2007)

Source page: https://510kreport.com/company/autogenomics