FDA applicant
Biolabs, Inc.
FDA records 3 decisions for Biolabs, Inc. (Mchenry, IL) from 1980 to 1981: 3 510(k) clearances. All are in product code KIS (Sera, Animal And Human). 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 Biolabs, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Biolabs, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Biolabs, 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