# Diagnostica Stago, Inc.

- Location (FDA's records): Parisppany, NJ
- FDA decisions: 25 (2001–2026): 25 510(k) clearances
- Names in FDA's records: Diagnostica Stago, Inc. (17); Diagnostica Stago S.A.S (3); Diagnostica Stago (2); Diagnostica Stago, Incorporated (2); Diagnostica-Stago (1)
- Product codes: JPA (8), GGN (3), KFF (3), DAP (2), GGP (2), GGC (1), GFO (1), GIR (1), LCO (1), GJS (1), JIX (1), JIT (1)
- Predicates its devices cite: 28 (12 its own); citations of its devices by later devices: 17 (12 its own)
- Recalls linked to its devices: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- American Bioproducts Co.: 8 (https://510kreport.com/company/american-bioproducts)
- bioMerieux, Inc.: 2 (https://510kreport.com/company/biomerieux)
- Instrumentation Laboratory CO: 2 (https://510kreport.com/company/instrumentation-laboratory)
- Precision Biologicals, Inc.: 1 (https://510kreport.com/company/precision-biologicals)
- Sherwood Medical Co.: 1 (https://510kreport.com/company/sherwood-medical)
- Dade Behring, Inc.: 1 (https://510kreport.com/company/dade-behring)
- Sigma Diagnostics, Inc.: 1 (https://510kreport.com/company/sigma-diagnostics)

## Firms that cite its devices most
- Hyphen Biomed: 1 (https://510kreport.com/company/hyphen-biomed)
- R2 Diagnostics, Inc.: 1 (https://510kreport.com/company/r2-diagnostics)
- Siemens Healthcare Diagnostics Products GmbH: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics-products)
- Instrumentation Laboratory CO: 1 (https://510kreport.com/company/instrumentation-laboratory)
- Diagnostics Stago S.A.S.: 1 (https://510kreport.com/company/diagnostics-stago)

## Its most-cited devices
- K010350: Sta -Calibrator HBPM/LMWH Kit (2001), cited by 2
- K003767: Asserachrom Hpia Test Kit (2001), cited by 2
- K010963: Sta-Liatest Free Protein S Test Kit (2001), cited by 2
- K082675: Sta-R Evolution Automated Multi-Parametric Analyzer (2008), cited by 1
- K093001: Sta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric Analyzer (2009), cited by 1
- K061803: Sta - Control LA 1+2 (2006), cited by 1

## Recent decisions
- K260214: STA® - Liquid Anti-Xa (Sep 24, 2026)
- K253658: STA Satellite Max® (Apr 27, 2026)
- K212183: STA R Max 3, STA Compact Max 3 (Jun 7, 2023)
- K211485: STA- NeoPTimal (Dec 23, 2022)
- K162227: STA® - Liatest® D-Di (Dec 10, 2016)
- K151867: Sta R Max (Aug 7, 2015)
- K141144: Sta Liatest D-DI (Sep 3, 2014)
- K120014: Sta- Coag Control (N+Abn) Plus (Mar 14, 2013)

Source page: https://510kreport.com/company/diagnostica-stago