510(k) Report

FDA applicant

Triangle Biomedical Sciences, Inc.

Palm Beach Gardens, FL6 decisions1996–19980 recalls

FDA records 6 decisions for Triangle Biomedical Sciences, Inc. (Palm Beach Gardens, FL) from 1996 to 1998: 6 510(k) clearances. Most are in product codes JOY (Device, Automated Cell-Locating) and DHN (Antinuclear Antibody, Indirect…). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Triangle Biomedical Sciences, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Triangle Biomedical Sciences, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Triangle Biomedical Sciences, 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 “Triangle”

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