510(k) Report

FDA applicant

Harris Mfg. Co.

Trenton, NJ2 decisions1988–19920 recalls

FDA records 2 decisions for Harris Mfg. Co. (Trenton, NJ) from 1988 to 1992: 2 510(k) clearances. Most are in product codes KSE (Refrigerator, Freezer, Blood Storage) and LMC (Camera, Multi Format, Radiological). 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, hematology panel, where it files most

How often FDA has decided Harris Mfg. Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Harris Mfg. Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Harris”

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