510(k) Report

FDA applicant

Immunetics, Inc.

Cambridge,, MA4 decisions1999–20040 recalls

FDA records 4 decisions for Immunetics, Inc. (Cambridge,, MA) from 1999 to 2004: 4 510(k) clearances. Most are in product codes LSR (Reagent, Borrelia Serological Reagent) and NRL (Enzyme Linked Immunoabsorbent Assay, Antibody…). 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 Immunetics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Immunetics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Immunetics, 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?

  • LSRReagent, Borrelia Serological Reagent3decisions
  • NRLEnzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K003754Immunetics C6 Lyme Elisa KitImmunetics, Inc. · 20011cites it

What has FDA decided for it lately?

  • K040407Quickelisa Anthrax-PA KitImmunetics, Inc. · 2004
  • K003754Immunetics C6 Lyme Elisa KitImmunetics, Inc. · 2001
  • K991062Qualicode B. Burgdorferi Igm Western Blot Kit, Model DK-C062-024Immunetics, Inc. · 1999
  • K991063Qualicode B. Burgdorferi Igg Western Blot Kit, Model DK-C052-024Immunetics, Inc. · 1999

All 4 as Immunetics, Inc. →