510(k) Report

FDA applicant

Miles, Inc.

Tarrytown, NY11 decisions1993–19950 recalls

FDA records 11 decisions for Miles, Inc. (Tarrytown, NY) from 1993 to 1995: 11 510(k) clearances. Most are in product codes GKZ (Counter, Differential Cell) and CGX (Alkaline Picrate, Colorimetry, Creatinine). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Miles, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Miles, Inc. 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.