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

    ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000

    K Number: K060353 · Decision May 3, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    87
    Applicant Total
    8
    Review Days
    79

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    Basic Information

    Device Name
    ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000
    K Number
    K060353
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Acro Biotech, LLC
    Date Received
    February 13, 2006
    Decision Date
    May 3, 2006
    Product Code
    LCM
    Advisory Committee
    Unknown
    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
    LCM Enzyme Immunoassay, Phencyclidine

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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
    K053037 ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100
    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
    K053032 ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000