510(k) Report

FDA applicant

Scientific Device Laboratory, Inc.

Mchenry, IL28 decisions1984–19941 recall

FDA records 28 decisions for Scientific Device Laboratory, Inc. (Mchenry, IL) from 1984 to 1994: 28 510(k) clearances. Most are in product codes LSC (Neisseria Controls) and LJG (Quality Control Slides). 1 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 Scientific Device Laboratory, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Scientific Device Laboratory, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Scientific Device 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?

  • LSCNeisseria Controls7decisions
  • LJGQuality Control Slides6decisions
  • JTSStains, Microbiologic3decisions
  • GTYAntigens, All Groups, Streptococcus Spp.3decisions
  • JSJCulture Media, Selective And Non-Differential2decisions
  • LIEReagent/Device, Inoculum Calibration1decision

Also: LKS (1), FLE (1), JSG (1), JTO (1), GSI (1), GGH (1).

What has FDA decided for it lately?

  • K935316Parasafe (R) FixativeScientific Device Laboratory, Inc. · 1994
  • K924893Microsporidium Control SlideScientific Device Laboratory, Inc. · 1993
  • K911059Turbidometric StandardScientific Device Laboratory, Inc. · 1991
  • K895848Pressure Steam SterilizersScientific Device Laboratory, Inc. · 1989
  • K890718Gram Stain Control SlideScientific Device Laboratory, Inc. · 19891 recall
  • K890670Cryptosporidium Control SlideScientific Device Laboratory, Inc. · 1989
  • K884069Snap N' Stain Iodine StainScientific Device Laboratory, Inc. · 1988
  • K884011Snap N' Stain Iron StainScientific Device Laboratory, Inc. · 1988

All 28 as Scientific Device Laboratory, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K890718Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm…Nov 3, 2003