510(k) Report

FDA applicant

Pm America, Inc.

Mchenry, IL5 decisions1980–19830 recalls

FDA records 5 decisions for Pm America, Inc. (Mchenry, IL) from 1980 to 1983: 5 510(k) clearances. Most are in product codes JQW (Station, Pipetting And Diluting, For Clinical…) and JJE (Analyzer, Chemistry (Photometric, Discrete)…). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Pm America, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Pm America, 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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