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

    AT HOME DRUG TEST, MODEL 9069

    K Number: K013412 · Decision Dec 6, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    17
    Applicant Total
    15
    Review Days
    52

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    Basic Information

    Device Name
    AT HOME DRUG TEST, MODEL 9069
    K Number
    K013412
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phamatech, Inc.
    Date Received
    October 15, 2001
    Decision Date
    December 6, 2001
    Product Code
    MVO
    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
    MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter

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    Other Clearances by Phamatech, Inc.

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    K070009 AT HOME DRUG TEST MODELS, 9308T AND 9308X
    K070098 QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC
    K043599 MOMENTS MENOPAUSE CHECK, MODEL 9113
    K043051 QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121
    K043167 PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X
    K040575 PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112
    K021409 AT HOME OVULATION TEST, MODEL 9032
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