510(k) Report

FDA applicant

Acumedia Manufacturers, Inc.

Mchenry, IL177 decisions1981–19880 recalls

FDA records 177 decisions for Acumedia Manufacturers, Inc. (Mchenry, IL) from 1981 to 1988: 177 510(k) clearances. Most are in product codes JSG (Culture Media, Non-Selective And…) and JSI (Culture Media, Selective And Differential). 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Acumedia Manufacturers, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • JSGCulture Media, Non-Selective And Non-Differential42decisions
  • JSICulture Media, Selective And Differential40decisions
  • JSJCulture Media, Selective And Non-Differential30decisions
  • JSHCulture Media, Non-Selective And Differential21decisions
  • JSKSupplement, Culture Media10decisions
  • JSACulture Media, Antibiotic Assay8decisions

Also: JSC (6), JSM (3), JTY (3), JSO (2), JTZ (2), LKA (2).

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K881577Modified Selective Streptococcus AgarAcumedia Manufacturers, Inc. · 19881cites it

What has FDA decided for it lately?

  • K881529Cary and Blair Transport MediumAcumedia Manufacturers, Inc. · 1988
  • K881536Antibiotic Medium #5 Streptomycin Assay AgarAcumedia Manufacturers, Inc. · 1988
  • K881556Trichomonas BrothAcumedia Manufacturers, Inc. · 1988
  • K881551Phenol Red Broth BaseAcumedia Manufacturers, Inc. · 1988
  • K881570Sabouraud Maltose AgarAcumedia Manufacturers, Inc. · 1988
  • K881568Wilkens Chalgren BrothAcumedia Manufacturers, Inc. · 1988
  • K881486Dnase Test AgarAcumedia Manufacturers, Inc. · 1988
  • K881557TryptoneAcumedia Manufacturers, Inc. · 1988

All 177 as Acumedia Manufacturers, Inc. →