FDA applicant
Biosan Laboratories, Inc.
FDA records 10 decisions for Biosan Laboratories, Inc. (Mchenry, IL) from 1983 to 1986: 10 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and KEA (Resins, Ion-Exchange). 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 Biosan Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Biosan Laboratories, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Biosan Laboratories, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report