FDA applicant
Biorent Diagnostic, Inc.
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
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.
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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