FDA applicant
Biohytech International, Inc.
FDA records 7 decisions for Biohytech International, Inc. (Chicago, IL) from 1986 to 1987: 7 510(k) clearances. Most are in product codes LJM (Antinuclear Antibody (Enzyme-Labeled)…) and DHN (Antinuclear Antibody, Indirect…). 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 Biohytech International, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Biohytech International, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Biohytech International, 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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