510(k) Report

FDA applicant

Mission Diagnostics

Holliston, MA2 decisions2002–20020 recalls

FDA records 2 decisions for Mission Diagnostics (Holliston, MA) in 2002: 2 510(k) clearances. All are in product code JIT (Calibrator, Secondary). 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 Mission Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mission Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Mission”

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