# Focus Diagnostics, Inc.

- Location (FDA's records): Cypress, CA
- FDA decisions: 18 (2007–2015): 16 510(k) clearances and 2 De Novo grants
- Names in FDA's records: Focus Diagnostics, Inc. (14); Focus Diagnostics (4)
- Product codes: OCC (4), MXJ (3), PGH (2), OYP (2), LJN (1), OQW (1), OOI (1), LSE (1), OMN (1), PGX (1), OQO (1)
- Predicates its devices cite: 18 (3 its own); citations of its devices by later devices: 8 (3 its own)
- Recalls linked to its devices: 7 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Prodesse, Inc.: 6 (https://510kreport.com/company/prodesse)
- Luminex Molecular Diagnostics, Inc.: 3 (https://510kreport.com/company/luminex-molecular-diagnostics)
- Centers for Disease Control and Prevention: 1 (https://510kreport.com/company/centers-for-disease-control-and-prevention)
- Cepheid: 1 (https://510kreport.com/company/cepheid)
- Meridian Bioscience, Inc.: 1 (https://510kreport.com/company/meridian-bioscience)
- Bd Diagnostics (Geneohm Sciences, Inc.): 1 (https://510kreport.com/company/bd-diagnostics-geneohm-sciences)
- Quidel Corp.: 1 (https://510kreport.com/company/quidel)
- QIAGEN GmbH: 1 (https://510kreport.com/company/qiagen)

## Firms that cite its devices most
- Luminex Corporation: 1 (https://510kreport.com/company/luminex)
- Gen-Probe Prodesse, Inc.: 1 (https://510kreport.com/company/gen-probe-prodesse)
- Cepheid: 1 (https://510kreport.com/company/cepheid)
- Midiagnostics NV: 1 (https://510kreport.com/company/midiagnostics)
- Diasorin Molecular, LLC: 1 (https://510kreport.com/company/diasorin-molecular)

## Its most-cited devices
- DEN130049: Simplexa HSV 1&2 Direct (2014), cited by 2
- K120413: Simplexa Flu a/B & RSV Direct, Simplexa Flu a/B & RSV Positive Control Pack (2012), cited by 2
- K100148: Simplexa Influenza a H1N1 (2009) Model MOL2500 (2010), cited by 2
- K142365: Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack (2014), cited by 1
- K143651: Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack (2015), cited by 1

## Recent decisions
- K152408: Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack (Sep 21, 2015)
- K150962: Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (Aug 28, 2015)
- K143651: Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack (Mar 18, 2015)
- K142365: Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack (Dec 5, 2014)
- K141458: Simplexa HSV 1&2 Direct/Positive Control Pack (Jul 1, 2014)
- DEN130049: Simplexa HSV 1&2 Direct (Mar 21, 2014)
- K120986: Stratify JCV Dxselect (Aug 16, 2012)
- K120413: Simplexa Flu a/B & RSV Direct, Simplexa Flu a/B & RSV Positive Control Pack (Jul 13, 2012)

Source page: https://510kreport.com/company/focus-diagnostics