510(k) Report

FDA applicant

Invitrogen Corporation

Grand Island2 decisions2002–20082 recalls

FDA records 2 decisions for Invitrogen Corporation (Grand Island) from 2002 to 2008: 1 510(k) clearance and 1 original PMA approval. Most are in product codes NYQ (Chromogenic In Situ Hybridization, Nucleic…) and NDS (Media, Culture, Ex Vivo, Tissue And Cell). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, pathology panel, where it files most

How often FDA has decided Invitrogen Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2018

2011: 12018: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Invitrogen Corporation 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?

  • NYQChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast…1decision
  • NDSMedia, Culture, Ex Vivo, Tissue And Cell1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K022086Aim-V (R) Medium, Model 087-0112Invitrogen Corporation · 20024cite it

What has FDA decided for it lately?

  • P050040Spot-Light HER2 Cish KitInvitrogen Corporation · 20081 recall
  • K022086Aim-V (R) Medium, Model 087-0112Invitrogen Corporation · 20021 recall

All 2 as Invitrogen Corporation →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K022086GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture…May 10, 2018Class II
  • P050040SPOT-Light" HER2 CISH Kit, catalog #84-0150, 20 tests/kit, labeled in part ***Invitrogen…Nov 14, 2011