510(k) Report

FDA applicant

Pwn Health Chicago, LLC

New York1 decision1999–19991 recall

FDA records 1 decision for Pwn Health Chicago, LLC (New York) in 1999: 1 original PMA approval. All are in product code QRO (Unnamed device). 1 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 Pwn Health Chicago, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pwn Health Chicago, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pwn Health Chicago, LLC 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?

  • QROUnnamed device1decision

What has FDA decided for it lately?

  • P980046Home Access Hepatitis C Check and Hepatitis C Check ExpressPwn Health Chicago, LLC · 19991 recall

The one decision as Pwn Health Chicago, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • P980046Home Access-Hepatitis C Check; At Home Telemedicine Test Service for Hepatitis C ; each…Oct 6, 2006