510(k) Report

FDA applicant

Difco Laboratories, Inc.

Detroit, MI121 decisions1979–19972 recalls

FDA records 121 decisions for Difco Laboratories, Inc. (Detroit, MI) from 1979 to 1997: 121 510(k) clearances. Most are in product codes JTN (Susceptibility Test Discs, Antimicrobial) and JTO (Discs, Strips And Reagents, Microorganism…). 2 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Difco Laboratories, Inc. since 2007.

Recalls per year

1in 2013

2009: 12013: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Difco Laboratories, 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?

  • JTNSusceptibility Test Discs, Antimicrobial41decisions
  • JTODiscs, Strips And Reagents, Microorganism Differentiation34decisions
  • GTZAntisera, All Groups, Streptococcus Spp.3decisions
  • MDBSystem, Blood Culturing3decisions
  • JSFCulture Media, Single Biochemical Test3decisions
  • JTWSystem, Transport, Aerobic3decisions

Also: KIR (3), LJP (2), LED (2), LIE (1), LFX (1), GTQ (1).

What has FDA decided for it lately?

  • K971120Dispens-O-Disc (TM) LevofloxacinDifco Laboratories, Inc. · 1997
  • K971211Dispens-O-Disc SparfloxacinDifco Laboratories, Inc. · 1997
  • K963508Dispens-O-Disc MeropenemDifco Laboratories, Inc. · 1996
  • K961148Cefepime Dispans-O-Disc (Cefeplime - 30MCG)Difco Laboratories, Inc. · 1996
  • K954783Dryslide CartarrhalisDifco Laboratories, Inc. · 1996
  • K954784Dryside NeisseriaDifco Laboratories, Inc. · 1996
  • K953129Esp Culture System - MycoDifco Laboratories, Inc. · 1995
  • K950706Dryslide CoagulaseDifco Laboratories, Inc. · 1995

All 121 as Difco Laboratories, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K896398BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic…Apr 12, 2013Class II
  • K842086BBL (tm) Lactophenol Cotton Blue Stain Droppers, Catalog number 261188, shelf package of…Sep 28, 2009