510(k) Report

FDA applicant

Bd Diagnostics

Durham2 decisions1995–19951 recall

FDA records 2 decisions for Bd Diagnostics (Durham) in 1995: 2 original PMA approvals. All are in product code MNM (Reader, Cervical Cytology Slide, Automated). 1 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, pathology panel, where it files most

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

FDA decisions per year

No FDA decision for Bd Diagnostics since 2007.

Recalls per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • MNMReader, Cervical Cytology Slide, Automated2decisions

What has FDA decided for it lately?

  • P940029Papnet (R) Testing SystemBd Diagnostics · 1995
  • P950009Autopap (R) 300 QC Automatic Pap Screener/QC SystemBd Diagnostics · 19951 recall

All 2 as Bd Diagnostics →

What has been recalled?

1 recall linked to its devices; the latest:

  • P950009BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398…Sep 21, 2018Class III