# Gen-Probe Prodesse, Inc.

- Location (FDA's records): Waukesha, WI
- FDA decisions: 10 (2010–2013): 10 510(k) clearances
- Product codes: OCC (4), OQW (2), OEM (2), PCH (1), OOU (1)
- Predicates its devices cite: 27 (4 its own); citations of its devices by later devices: 15 (4 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
- Luminex Molecular Diagnostics, Inc.: 11 (https://510kreport.com/company/luminex-molecular-diagnostics)
- Prodesse, Inc.: 8 (https://510kreport.com/company/prodesse)
- Centers for Disease Control and Prevention: 1 (https://510kreport.com/company/centers-for-disease-control-and-prevention)
- Focus Diagnostics, Inc.: 1 (https://510kreport.com/company/focus-diagnostics)
- Quidel Corp.: 1 (https://510kreport.com/company/quidel)

## Firms that cite its devices most
- Iquum, Inc.: 2 (https://510kreport.com/company/iquum)
- Cepheid: 2 (https://510kreport.com/company/cepheid)
- Hologic, Inc.: 2 (https://510kreport.com/company/hologic)
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)
- Nanosphere, Inc.: 1 (https://510kreport.com/company/nanosphere)
- Argene SA: 1 (https://510kreport.com/company/argene)
- QIAGEN GmbH: 1 (https://510kreport.com/company/qiagen)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)

## Its most-cited devices
- K110968: Proflu+ Assay (2011), cited by 4
- K101855: Profast+ Assay (2010), cited by 3
- K132129: Prodesse Proflu+ Assay (2013), cited by 3
- K102952: Prodesse Proadeno (2010), cited by 2
- K123274: Progastro SSCS Assay (2013), cited by 1
- K123838: Pro HMPV+ Assay (2013), cited by 1

## Recent decisions
- K132237: Prodesse Profast+ Assay (Aug 26, 2013)
- K132238: Proparaflu+ Assay (Aug 26, 2013)
- K132159: Proadeno+ Assay (Aug 14, 2013)
- K132200: Pro HMPV+ Assay (Aug 14, 2013)
- K132129: Prodesse Proflu+ Assay (Aug 9, 2013)
- K123274: Progastro SSCS Assay (Jan 16, 2013)
- K123838: Pro HMPV+ Assay (Jan 16, 2013)
- K110968: Proflu+ Assay (Jun 27, 2011)

Source page: https://510kreport.com/company/gen-probe-prodesse