FDA applicant
Miles Laboratories, Inc.
FDA records 159 decisions for Miles Laboratories, Inc. (Mchenry, IL) from 1976 to 1988: 158 510(k) clearances and 1 original PMA approval. Most are in product codes CGA (Glucose Oxidase, Glucose) and JQP (Calculator/Data Processing Module, For…). 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 Miles Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Miles Laboratories, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Miles Laboratories, Inc.’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 “Miles”
FDA records each applicant name separately; these may or may not be the same firm.