ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000

Enzyme Immunoassay, Amphetamine

ACRO BIOTECH LLC.

The following data is part of a premarket notification filed by Acro Biotech Llc. with the FDA for Acro Biotech Llc Rapid Amphetamine Urine Test; Catalog# Amp001000.

Pre-market Notification Details

Device IDK053032
510k NumberK053032
Device Name:ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000
ClassificationEnzyme Immunoassay, Amphetamine
Applicant ACRO BIOTECH LLC. 9500 7TH STREET UNIT M Rancho Cucamonga,  CA  91730 -9094
ContactGregory Lee
CorrespondentGregory Lee
ACRO BIOTECH LLC. 9500 7TH STREET UNIT M Rancho Cucamonga,  CA  91730 -9094
Product CodeDKZ  
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-27
Decision Date2006-02-09

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