510(k) Report

FDA applicant

Petra Biomedical Products, Inc.

Mchenry, IL4 decisions1983–19870 recalls

FDA records 4 decisions for Petra Biomedical Products, Inc. (Mchenry, IL) from 1983 to 1987: 4 510(k) clearances. Most are in product codes JSS (Kit, Identification, Enterobacteriaceae) and JTO (Discs, Strips And Reagents, Microorganism…). 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 Petra Biomedical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Petra Biomedical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Petra”

FDA records each applicant name separately; these may or may not be the same firm.