510(k) Report

FDA applicant

Quality Assurance Laboratory, Inc.

Mchenry, IL11 decisions1980–19800 recalls

FDA records 11 decisions for Quality Assurance Laboratory, Inc. (Mchenry, IL) in 1980: 11 510(k) clearances. Most are in product codes JSG (Culture Media, Non-Selective And…) and JSH (Culture Media, Non-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 Quality Assurance Laboratory, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Quality Assurance Laboratory, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Quality Assurance Laboratory, 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-Differential3decisions
  • JSHCulture Media, Non-Selective And Differential3decisions
  • JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth2decisions
  • JSICulture Media, Selective And Differential2decisions
  • JTYCulture Media, For Isolation Of Pathogenic Neisseria1decision

What has FDA decided for it lately?

  • K800986Trypticase Soy Agar W5% Sheep BloodQuality Assurance Laboratory, Inc. · 1980
  • K800987Mueller Hinton AgarQuality Assurance Laboratory, Inc. · 1980
  • K800981Chocolate Agar W/EnrichmentsQuality Assurance Laboratory, Inc. · 1980
  • K800978Xylose Lysine Desoxycholate AgarQuality Assurance Laboratory, Inc. · 1980
  • K800977Thayer-Martin AgarQuality Assurance Laboratory, Inc. · 1980
  • K800983Macconkey AgarQuality Assurance Laboratory, Inc. · 1980
  • K800979Mueller Hintin Agar W/5% Sheep BloodQuality Assurance Laboratory, Inc. · 1980
  • K800985Thioglycollate Med. W/O IndicatorQuality Assurance Laboratory, Inc. · 1980

All 11 as Quality Assurance Laboratory, Inc. →