FDA applicant
Protos Laboratories
FDA records 6 decisions for Protos Laboratories (Mchenry, IL) from 1979 to 1980: 6 510(k) clearances. Most are in product codes DCK (C-Reactive Protein, Antigen, Antiserum, And…) and DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control). 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 Protos Laboratories’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Protos Laboratories since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Protos Laboratories’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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