510(k) Report

FDA applicant

Miles Pharmaceuticals

West Haven, CT2 decisions1982–19870 recalls

FDA records 2 decisions for Miles Pharmaceuticals (West Haven, CT) from 1982 to 1987: 2 510(k) clearances. All are in product code JTT (Susceptibility Test Powders, Antimicrobial). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Miles Pharmaceuticals’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Miles Pharmaceuticals since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Miles Pharmaceuticals by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Miles”

FDA records each applicant name separately; these may or may not be the same firm.