510(k) Report

FDA applicant

Centocor, Inc.

Malvern, PA3 decisions1982–19970 recalls

FDA records 3 decisions for Centocor, Inc. (Malvern, PA) from 1982 to 1997: 3 510(k) clearances. Most are in product codes JOZ (System, Automated Platelet Aggregation) and MOI (System, Test, Immunological, Antigen, Tumor). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Centocor, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • JOZSystem, Automated Platelet Aggregation1decision
  • MOISystem, Test, Immunological, Antigen, Tumor1decision
  • GOIAntiserum, Fluorescent, Rabies Virus1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K954997Centocor Aggrestat, Collagen Reagent, Control ReagentCentocor, Inc. · 19961cites it
  • K963803Centocor CA 15-3 Ria Model NO. 800-033Centocor, Inc. · 19971cites it

What has FDA decided for it lately?

  • K963803Centocor CA 15-3 Ria Model NO. 800-033Centocor, Inc. · 1997
  • K954997Centocor Aggrestat, Collagen Reagent, Control ReagentCentocor, Inc. · 1996
  • K820499Fitc Anti-Rabies Monoclonal GlobulinCentocor, Inc. · 1982

All 3 as Centocor, Inc. →