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

    RENIN RADIOIMMUNOASSAY TEST KIT

    K Number: K842966 · Decision Oct 11, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    15
    Applicant Total
    25
    Review Days
    76

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    Basic Information

    Device Name
    RENIN RADIOIMMUNOASSAY TEST KIT
    K Number
    K842966
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1085
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Serono Diagnostics, Inc.
    Date Received
    July 27, 1984
    Decision Date
    October 11, 1984
    Product Code
    CIB
    Advisory Committee
    Clinical Chemistry
    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
    CIB Radioimmunoassay, Angiotensin I And Renin

    Similar 510(k) Clearances

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    ACTIVE RENIN IRMA

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    NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)

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    ACTIVE RENIN IRMA MODEL NUMBER DSL-25100

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    Other Clearances by Serono Diagnostics, Inc.

    K Number Device Name
    K953598 SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS
    K942051 SR1 DHEA-S ENZYME IMMUNOASSAY
    K883085 T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS
    K882340 LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA
    K880388 T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE
    K874866 T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE
    K873431 PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH
    K873186 LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA
    K873400 PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA
    K872862 PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS
    Search all 25 clearances from Serono Diagnostics, Inc. →