FDA applicant
Machlett Laboratories, Inc.
FDA records 4 decisions for Machlett Laboratories, Inc. (Mchenry, IL) from 1978 to 1982: 4 510(k) clearances. Most are in product codes IYX (Camera, Scintillation (Gamma)) and IXF (Test-Pattern, Radiographic). 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 Machlett Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Machlett Laboratories, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Machlett Laboratories, 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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