FDA applicant

Access Bio, Inc.

Somerset, NJ3 decisions2020–20250 recalls

FDA records 3 decisions for Access Bio, Inc. (Somerset, NJ) from 2020 to 2025: 3 510(k) clearances. Most are in product codes QYT (Over-The-Counter Covid-19 Antigen Test) and PSZ (Devices Detecting Influenza A, B, And C Virus…). Its devices cite 3 predicates, 0 of them its own earlier devices. 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, microbiology panel, where it files most

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

FDA decisions per year

2in 2025

2020high 2 (2025) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Access Bio, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Access Bio, 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 “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 Incorporate 4 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, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Access”