510(k) Report

FDA applicant

Biolabs, Inc.

Mchenry, IL3 decisions1980–19810 recalls

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, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

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.

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

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.

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