FDA applicant

Boditech Diagnostics, Inc.

East Stroudsburg, PA1 decision2007–20070 recalls

FDA records 1 decision for Boditech Diagnostics, Inc. (East Stroudsburg, PA) in 2007: 1 510(k) clearance. All are in product code DCN (System, Test, C-Reactive Protein). 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, immunology panel, where it files most

How often FDA has decided Boditech Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Boditech”

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

Boditech Med, Inc. 2

Boditech Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Boditech”