# Fisher Diagnostics

- Location (FDA's records): Middletown, VA
- FDA decisions: 16 (1983–2017): 16 510(k) clearances
- Product codes: MMI (2), JHJ (2), JZO (2), JIT (1), DIF (1), GGN (1), JHX (1), PRI (1), DKC (1), JIX (1), GKP (1), DDR (1)
- Predicates its devices cite: 10 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nichols Institute Diagnostics: 2 (https://510kreport.com/company/nichols-institute-diagnostics)
- Abbott Laboratories: 2 (https://510kreport.com/company/abbott-laboratories)
- Medical Laboratory Automation Systems, Inc.: 2 (https://510kreport.com/company/medical-laboratory-automation-systems)
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)
- Brahms GmbH: 1 (https://510kreport.com/company/brahms)
- Axis-Shield Diagnostics, Ltd.: 1 (https://510kreport.com/company/axis-shield-diagnostics)
- Pacific Hemostasis: 1 (https://510kreport.com/company/pacific-hemostasis)

## Firms that cite its devices most
- Radiometer Medical Aps: 2 (https://510kreport.com/company/radiometer-medical)
- Wortham Laboratories, Inc.: 1 (https://510kreport.com/company/wortham-laboratories)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Instrumentation Laboratory CO: 1 (https://510kreport.com/company/instrumentation-laboratory)

## Its most-cited devices
- K042924: Architect Stat Myo Immunoassay (2005), cited by 2
- K010750: Pacific Hemostasis Inr Control Plasmas, Model Catalog 100560 (2001), cited by 1
- K052407: Architect Anti-Tpo Immunoassay, Calibrators & Controls (2006), cited by 1
- K023362: Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus Kaolin (2002), cited by 1

## Recent decisions
- K170652: ARCHITECT B.R.A.H.M.S PCT,  ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls (Jun 1, 2017)
- K070640: Architect Stat Troponin-1; Myoglobin (Sep 13, 2007)
- K052407: Architect Anti-Tpo Immunoassay, Calibrators & Controls (Jul 18, 2006)
- K052308: Architect Anti-TG Immunoassay Reagents, Calibrators, Controls and System Assay CD-Rom (May 10, 2006)
- K042924: Architect Stat Myo Immunoassay (Jan 24, 2005)
- K041192: Architect Stat Troponin-I Immunoassay (Aug 12, 2004)
- K041596: Architect Stat CK-MB Immunoassay (Jul 21, 2004)
- K023362: Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus Kaolin (Dec 9, 2002)

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