510(k) Report

FDA applicant

Biorent Diagnostic, Inc.

Mchenry, IL11 decisions1981–19830 recalls

FDA records 11 decisions for Biorent Diagnostic, Inc. (Mchenry, IL) from 1981 to 1983: 11 510(k) clearances. Most are in product codes JHS (Differential Rate Kinetic Method, Cpk Or…) and CFH (Tetrazolium Int Dye-Diaphorase, Lactate…). 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 Biorent Diagnostic, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biorent Diagnostic, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biorent Diagnostic, 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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