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

    IMMUCHEM COVALENT-COAT RIA KIT

    K Number: K830962 · Decision May 4, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    13
    Applicant Total
    18
    Review Days
    37

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    Basic Information

    Device Name
    IMMUCHEM COVALENT-COAT RIA KIT
    K Number
    K830962
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Immuchem Corp.
    Date Received
    March 28, 1983
    Decision Date
    May 4, 1983
    Product Code
    DPO
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DPO Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.

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    Other Clearances by Immuchem Corp.

    K Number Device Name
    K883726 THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL
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    K871542 HPROLACTIN KIT
    K865071 THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT
    K864144 LUTEINIZING HORMONE (LH-IRMA) RIA KIT
    K860559 ANDROSTENEDIONE 125I KIT BY RIA
    K854094 IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS
    K822509 COVALENT COAT RIA KIT
    K822140 IMMUCHEM COVALENT-COAT
    K820329 ESTRADIOL KIT BY RIA
    Search all 18 clearances from Immuchem Corp. →