510(k) Report

FDA applicant

Direct Access Diagnostics

Bridgewater, NJ2 decisions1996–19960 recalls

FDA records 2 decisions for Direct Access Diagnostics (Bridgewater, NJ) in 1996: 2 510(k) clearances. All are in product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). 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 Direct Access Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Direct Access Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Direct Access 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?

  • LCXKit, Test, Pregnancy, Hcg, Over The Counter2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K962521Factplus One Step Pregnancy TestDirect Access Diagnostics · 19961cites it

What has FDA decided for it lately?

  • K964108Fact Plus Pregnancy TestDirect Access Diagnostics · 1996
  • K962521Factplus One Step Pregnancy TestDirect Access Diagnostics · 1996

All 2 as Direct Access Diagnostics →

Other applicant names beginning “Direct”

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

Direct Solutions 5Direct Digital Imaging Technology (Beijing), Inc. 2Direct Import Marketing Co. 1