510(k) Report

FDA applicant

Fisher Diagnostics

Middletown, VA16 decisions1983–20178 recalls

FDA records 16 decisions for Fisher Diagnostics (Middletown, VA) from 1983 to 2017: 16 510(k) clearances. Most are in product codes MMI (Immunoassay Method, Troponin Subunit) and JHJ (Agglutination Method, Human Chorionic…). Its devices cite 10 predicates, 0 of them its own earlier devices. 8 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Fisher Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007: 12017: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2025

2007: 12012: 12022: 22023: 12024: 12025: 1
2007high 2 (2022) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Fisher Diagnostics by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fisher Diagnostics’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MMIImmunoassay Method, Troponin Subunit2decisions
  • JHJAgglutination Method, Human Chorionic Gonadotropin2decisions
  • JZOSystem, Test, Thyroid Autoantibody2decisions
  • JITCalibrator, Secondary1decision
  • DIFDrug Mixture Control Materials1decision
  • GGNPlasma, Coagulation Control1decision

Also: JHX (1), PRI (1), DKC (1), JIX (1), GKP (1), DDR (1).

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K042924Architect Stat Myo ImmunoassayFisher Diagnostics · 20052cite it
  • K010750Pacific Hemostasis Inr Control Plasmas, Model Catalog 100560Fisher Diagnostics · 20011cites it
  • K052407Architect Anti-Tpo Immunoassay, Calibrators & ControlsFisher Diagnostics · 20061cites it
  • K023362Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus KaolinFisher Diagnostics · 20021cites it

What has FDA decided for it lately?

  • K170652ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT ControlsFisher Diagnostics · 2017
  • K070640Architect Stat Troponin-1; MyoglobinFisher Diagnostics · 2007
  • K052407Architect Anti-Tpo Immunoassay, Calibrators & ControlsFisher Diagnostics · 20062 recalls
  • K052308Architect Anti-TG Immunoassay Reagents, Calibrators, Controls and System Assay CD-RomFisher Diagnostics · 2006
  • K042924Architect Stat Myo ImmunoassayFisher Diagnostics · 20052 recalls
  • K041192Architect Stat Troponin-I ImmunoassayFisher Diagnostics · 20044 recalls
  • K041596Architect Stat CK-MB ImmunoassayFisher Diagnostics · 2004
  • K023362Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus KaolinFisher Diagnostics · 2002

All 16 as Fisher Diagnostics →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K052407Abbott Diagnostics Arc Anti-Tpo Assay 100TST B Reagent.Apr 24, 2025Class II
  • K042924ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.Feb 21, 2024Class II
  • K052407Alinity i Anti-TPO Reagent Kit, List Number 09P3521Apr 24, 2023Class III
  • K041192ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27Jul 26, 2022Class II
  • K042924ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin…Mar 8, 2022Class II
  • K041192ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro…Apr 11, 2012

Other applicant names beginning “Fisher”

FDA records each applicant name separately; these may or may not be the same firm.

Fisher Scientific Co., LLC 90Fisher & Paykel Healthcare, Ltd. 83Fisher & Paykel Electronics, Ltd. 17Fisher & Paykel Allied Products, Ltd. 12Fisher and Paykel Healthcare Limited 4Fisher Imaging Corp. 3Fisher Price 2