BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100

    K Number: K053037 · Decision Jun 15, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    214
    Applicant Total
    8
    Review Days
    231

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    Basic Information

    Device Name
    ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100
    K Number
    K053037
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Acro Biotech, LLC
    Date Received
    October 27, 2005
    Decision Date
    June 15, 2006
    Product Code
    DJG
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DJG Enzyme Immunoassay, Opiates

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    Other Clearances by Acro Biotech, LLC

    K Number Device Name
    K060355 ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000
    K060354 ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000
    K053033 ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000
    K053034 ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000
    K053035 ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000
    K060353 ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000
    K053032 ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000