ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000— 510(k) K053034

Name: FDA 510(k) clearance K053034
Creator: U.S. Food and Drug Administration
Published: 2006-06-06

Substantially Equivalent

Acro Biotech, LLC

FDA 510(k) clearance K053034 for ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000, Substantially Equivalent on 2006-06-06. Applicant: Acro Biotech, LLC. Device class: 2.

Clearance details

Applicant: Acro Biotech, LLC
Product code: Code LDJ
Device class: Class 2
Regulation: 21 CFR 862.3870
Advisory panel: Clinical Toxicology
Date received: 2005-10-27
Decision date: 2006-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Cucamonga, CA, US

Download summary PDF View on FDA.gov ↗

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