510(k) Report

FDA applicant

Mainline Technology, Inc.

Ann Arbor, MI1 decision2003–20030 recalls

FDA records 1 decision for Mainline Technology, Inc. (Ann Arbor, MI) in 2003: 1 510(k) clearance. All are in product code JHI (Visual, Pregnancy Hcg, Prescription Use). 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 Mainline Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mainline Technology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mainline Technology, 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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