510(k) Report

FDA applicant

Perimmune, Inc.

Rockville, MD2 decisions1997–19970 recalls

FDA records 2 decisions for Perimmune, Inc. (Rockville, MD) in 1997: 2 510(k) clearances. Most are in product codes MMW (System, Test, Tumor Marker, Monitoring, Bladder) and DFC (Lipoprotein, Low-Density, Antigen, Antiserum…). Its devices cite 2 predicates, 0 of them its own earlier devices. 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Perimmune, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Perimmune, 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?

  • MMWSystem, Test, Tumor Marker, Monitoring, Bladder1decision
  • DFCLipoprotein, Low-Density, Antigen, Antiserum, Control1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K970353Aura Tek FDPPerimmune, Inc. · 19971cites it

What has FDA decided for it lately?

  • K970302Apo-Tek LP (a)Perimmune, Inc. · 1997
  • K970353Aura Tek FDPPerimmune, Inc. · 1997

All 2 as Perimmune, Inc. →