510(k) Report

FDA applicant

Gibco Laboratories Life Technologies, Inc.

Mchenry, IL67 decisions1976–198714 recalls

FDA records 67 decisions for Gibco Laboratories Life Technologies, Inc. (Mchenry, IL) from 1976 to 1987: 67 510(k) clearances. Most are in product codes JSJ (Culture Media, Selective And Non-Differential) and JSK (Supplement, Culture Media). 14 recalls are linked to its devices, 9 Class I.

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 Gibco Laboratories Life Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gibco Laboratories Life Technologies, Inc. since 2007.

Recalls per year

1in 2025

2009: 12011: 12021: 22022: 9, 9 Class I2025: 1
2007high 9 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Gibco Laboratories Life Technologies, 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?

  • JSJCulture Media, Selective And Non-Differential18decisions
  • JSKSupplement, Culture Media7decisions
  • JSHCulture Media, Non-Selective And Differential5decisions
  • JTYCulture Media, For Isolation Of Pathogenic Neisseria5decisions
  • JSICulture Media, Selective And Differential4decisions
  • JSGCulture Media, Non-Selective And Non-Differential4decisions

Also: JTZ (3), KIW (2), JSL (2), KZI (2), JTW (2), JSF (2).

Who builds on its devices?

Later devices cite its devices 6 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.

  • K863821Mueller Hinton Agar W/4%Nacl and OxacillinGibco Laboratories Life Technologies, Inc. · 19865cite it
  • K871855Sorbitol Macconkey (Smac) Agar, Dri & Pre-FormGibco Laboratories Life Technologies, Inc. · 19871cites it

What has FDA decided for it lately?

  • K871855Sorbitol Macconkey (Smac) Agar, Dri & Pre-FormGibco Laboratories Life Technologies, Inc. · 1987
  • K871541Martin-Lewis Agar W/Reduced Vancomycin C0226Gibco Laboratories Life Technologies, Inc. · 1987
  • K870134Mcbride Listeria Agar W/Cycloheximide, Dri & PreGibco Laboratories Life Technologies, Inc. · 1987
  • K864755Pseudomonas Cepacia Selective Agar, Dri & Pre-FormGibco Laboratories Life Technologies, Inc. · 1987
  • K864014Lombard Dowell Agar BaseGibco Laboratories Life Technologies, Inc. · 1986
  • K863821Mueller Hinton Agar W/4%Nacl and OxacillinGibco Laboratories Life Technologies, Inc. · 19861 recall
  • K863820Dri-Form: Gbna Listeria Medium NO. M22300Gibco Laboratories Life Technologies, Inc. · 1986
  • K863289CDC Anaerobic Agar W/Sheep Blood, Kana-&VancomycinGibco Laboratories Life Technologies, Inc. · 1986

All 67 as Gibco Laboratories Life Technologies, Inc. →

What has been recalled?

14 recalls linked to its devices; the latest:

  • K7906871. Camhb W/LHB, Manual, 11ML, 10/Box YCP112-10 2. Brucella Broth, 11ML, 10/Box YT3450Nov 12, 2025Class II
  • K880641Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD ASTOct 20, 2022Class I
  • K880641Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD ASTOct 20, 2022Class I
  • K880641Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD ASTOct 20, 2022Class I
  • K880641Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD ASTOct 20, 2022Class I
  • K880641Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD ASTOct 20, 2022Class I