FDA applicant

Biotech Atlantic, Inc.

Eatontown, NJ4 decisions1994–20030 recalls

FDA records 4 decisions for Biotech Atlantic, Inc. (Eatontown, NJ) from 1994 to 2003: 4 510(k) clearances. Most are in product codes LCX (Kit, Test, Pregnancy, Hcg, Over The Counter) and DHA (System, Test, Human Chorionic Gonadotropin). Its devices cite 4 predicates, 4 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Biotech Atlantic, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biotech Atlantic, 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 “Biotech”

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

Biotech Dental, Sas 4 Biotech Research Laboratories, Inc. 2 Biotech One, Inc. 2 Biotech Dental Smilers, Sas 1 Biotech Lubricants, Ltd. 1 Biotech, Inc. 1 Biotech Medical Instruments Corp. 1

Biotech Atlantic, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Biotech”