ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000— 510(k) K053032

Name: FDA 510(k) clearance K053032
Creator: U.S. Food and Drug Administration
Published: 2006-02-09

Substantially Equivalent

Acro Biotech, LLC

FDA 510(k) clearance K053032 for ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000, Substantially Equivalent on 2006-02-09. Applicant: Acro Biotech, LLC. Device class: 2.

Clearance details

Applicant: Acro Biotech, LLC
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2005-10-27
Decision date: 2006-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Cucamonga, CA, US

Download summary PDF View on FDA.gov ↗

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