FDA applicant

Direct Solutions

Westford, MA5 decisions1995–19962 recalls

FDA records 5 decisions for Direct Solutions (Westford, MA) from 1995 to 1996: 5 510(k) clearances. Most are in product codes GGM (Control, Hemoglobin) and JJX (Single (Specified) Analyte Controls (Assayed…). 2 recalls are 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 Direct Solutions’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Direct Solutions since 2007.

Recalls per year

2in 2018

2007high 2 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Direct”

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

Direct Access Diagnostics 2 Direct Digital Imaging Technology (Beijing), Inc. 2 Direct Import Marketing Co. 1

Direct Solutions

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Direct”