FDA applicant
Alpha Gamma Laboratory
FDA records 4 decisions for Alpha Gamma Laboratory (Mchenry, IL) from 1978 to 1981: 4 510(k) clearances. Most are in product codes CGR (Radioimmunoassay, Cortisol) and CDP (Radioimmunoassay, Total Triiodothyronine). 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 Alpha Gamma Laboratory’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Alpha Gamma Laboratory since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Alpha Gamma Laboratory’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) ReportOther applicant names beginning “Alpha”
FDA records each applicant name separately; these may or may not be the same firm.