510(k) Report

FDA applicant

Trouble Shooter Consuling, Inc.

Rome, IT1 decision2004–20040 recalls

FDA records 1 decision for Trouble Shooter Consuling, Inc. (Rome, IT) in 2004: 1 510(k) clearance. All are in product code JJX (Single (Specified) Analyte Controls (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 Trouble Shooter Consuling, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Trouble Shooter Consuling, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Trouble Shooter Consuling, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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