510(k) Report

FDA applicant

Behring Diagnostics, Inc.

Westwood, MA145 decisions1976–19977 recalls

FDA records 145 decisions for Behring Diagnostics, Inc. (Westwood, MA) from 1976 to 1997: 145 510(k) clearances. Most are in product codes JJX (Single (Specified) Analyte Controls (Assayed…) and JPA (System, Multipurpose For In Vitro Coagulation…). Its devices cite 11 predicates, 5 of them its own earlier devices. 7 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Behring Diagnostics, Inc. since 2007.

Recalls per year

1in 2021

2015: 12016: 12017: 12021: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Behring Diagnostics, Inc.’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?

  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)7decisions
  • JPASystem, Multipurpose For In Vitro Coagulation Studies5decisions
  • LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus5decisions
  • JJQColorimeter, Photometer, Spectrophotometer For Clinical Use5decisions
  • JJYMulti-Analyte Controls, All Kinds (Assayed)5decisions
  • DHRSystem, Test, Rheumatoid Factor5decisions

Also: GGP (5), JIX (4), JZW (4), DDR (3), JZG (3), GTQ (3).

Whose devices does it build on?

Its devices cite 11 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 91 times; 5 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.

  • K860894Behring Nephelometer SystemBehring Diagnostics, Inc. · 198617cite it
  • K955278Behring Coagulation TimerBehring Diagnostics, Inc. · 19967cite it
  • K962373N/T Rheumatology Control SL/1 and SL/2Behring Diagnostics, Inc. · 19966cite it
  • K902154NA Latex Myoglobin TestBehring Diagnostics, Inc. · 19904cite it
  • K964527N Rheumatology Standard SLBehring Diagnostics, Inc. · 19974cite it
  • K942328N Latex RFBehring Diagnostics, Inc. · 19944cite it

What has FDA decided for it lately?

  • K973832Opus HLH ControlsBehring Diagnostics, Inc. · 1997
  • K972929N Antiserum to Human AlbuminBehring Diagnostics, Inc. · 1997
  • K972840N Antiserum to Human TransferrinBehring Diagnostics, Inc. · 1997
  • K973202Modification of Opus Ferritin Test SystemBehring Diagnostics, Inc. · 1997
  • K972316Opus D-DimerBehring Diagnostics, Inc. · 1997
  • K972116Von Willebrand ReagentBehring Diagnostics, Inc. · 1997
  • K972011Opus EthanolBehring Diagnostics, Inc. · 1997
  • K971600Emit Calibrator B Level 1 (Cutoff)/Emit Calibrator B Level 2 (High)Behring Diagnostics, Inc. · 1997

All 145 as Behring Diagnostics, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K970431BCS XP System: Multipurpose system for in vitro coagulation studies. Product code…Mar 2, 2021Class II
  • K970645BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC…Oct 17, 2017Class II
  • K970431BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro…Jan 14, 2016Class II
  • K924396Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro diagnostic…May 11, 2015Class II
  • K924396Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency TestJul 8, 2005
  • K970645BC Thrombin Reagent . Thrombin Time TestJul 21, 2004