510(k) Report

FDA applicant

Flow Cytometry Standards Corp.

Research Triangle Park, NC1 decision1985–19850 recalls

FDA records 1 decision for Flow Cytometry Standards Corp. (Research Triangle Park, NC) in 1985: 1 510(k) clearance. All are in product code JIW (Calibrator, Surrogate). 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 Flow Cytometry Standards Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Flow Cytometry Standards Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Flow”

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