FDA applicant

Access Bio Incorporate

North Brunswick, NJ4 decisions2003–20050 recalls

FDA records 4 decisions for Access Bio Incorporate (North Brunswick, NJ) from 2003 to 2005: 4 510(k) clearances. Most are in product codes DHA (System, Test, Human Chorionic Gonadotropin) and 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 Access Bio Incorporate’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Access Bio Incorporate since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Access Bio Incorporate’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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Other applicant names beginning “Access”

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

Access Scientific, Inc. 14 Access Surgical Intl., Inc. 9 Access Vascular, Inc. 9 Access / God Loves You 4 Access Point Medical, LLC 4 Access Bio, Inc. 3 Access Devices, Inc. 3 Access Pharmaceuticals, Inc. 2 Access Battery, Inc. 2 Access Radiology Corp. 2 Access Cardiosystems, Inc. 2 Access Point Technologies Ep, Inc. 1

Access Bio Incorporate

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Access”