FDA applicant

Acro Biotech, LLC

Rancho Cucamonga, CA10 decisions2006–20180 recalls

FDA records 10 decisions for Acro Biotech, LLC (Rancho Cucamonga, CA) from 2006 to 2018: 10 510(k) clearances. Most are in product codes DJC (Thin Layer Chromatography, Methamphetamine) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Acro Biotech, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical toxicology panel, where it files most

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

FDA decisions per year

2in 2018

2007high 2 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Acro Biotech, LLC’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 “Acro”

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

Acro Biomedical Co., Ltd. 4 Acro-Poly, Inc. 1 Acro Composites, LLC 1

Acro Biotech, LLC

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Acro”