510(k) Report

FDA applicant

Compass Bioscience

Duarte, CA2 decisions2006–20060 recalls

FDA records 2 decisions for Compass Bioscience (Duarte, CA) in 2006: 2 510(k) clearances. Most are in product codes JJX (Single (Specified) Analyte Controls (Assayed…) and JJY (Multi-Analyte Controls, All Kinds (Assayed)). 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 Compass Bioscience’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Compass Bioscience since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Compass”

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