FDA applicant
New England Immunology Assoc.
FDA records 4 decisions for New England Immunology Assoc. (Mchenry, IL) from 1978 to 1981: 4 510(k) clearances. Most are in product codes DBF (Ferritin, Antigen, Antiserum, Control) and JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited). 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 New England Immunology Assoc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for New England Immunology Assoc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like New England Immunology Assoc.’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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