ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100— 510(k) K053037

Name: FDA 510(k) clearance K053037
Creator: U.S. Food and Drug Administration
Published: 2006-06-15

Substantially Equivalent

Acro Biotech, LLC

FDA 510(k) clearance K053037 for ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100, Substantially Equivalent on 2006-06-15. Applicant: Acro Biotech, LLC. Device class: 2.

Clearance details

Applicant: Acro Biotech, LLC
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2005-10-27
Decision date: 2006-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Cucamonga, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DJG

view all

K252684 — Labcorp Fentanyl Urine Visual Test2026-01-29
K250741 — Evidence MultiSTAT DOA Urine MultiPlex2026-01-23
K253082 — LZI Buprenorphine II Enzyme Immunoassay2026-01-16
K252520 — SEFRIA Hydrocodone Oral Fluid2025-09-11
K251972 — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative +1 more2025-08-15

More clearances from Acro Biotech, LLC

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.