BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    LAS-R HUMAN PREALBUMIN TEST

    K Number: K772329 · Decision Feb 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    10
    Applicant Total
    44
    Review Days
    44

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    LAS-R HUMAN PREALBUMIN TEST
    K Number
    K772329
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5060
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Hyland Therapeutic Div., Travenol Laboratories
    Date Received
    December 21, 1977
    Decision Date
    February 3, 1978
    Product Code
    JZJ
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JZJ Prealbumin, Antigen, Antiserum, Control

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JZJ), ordered by most recent decision date.

    RANDOX PREALBUMIN

    FDA 510(k)
    FDA Class 1 ·Immunology

    TINA-QUANT PREALBUMIN

    FDA 510(k)
    FDA Class 1 ·Immunology

    HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT

    FDA 510(k)
    FDA Class 1 ·Immunology

    PREALBUMIN IMMUNOLOGICAL NL TEST KIT

    FDA 510(k)
    FDA Class 1 ·Immunology

    SPQ(TM) TEST SYSTEM FOR PREALBUMIN

    FDA 510(k)
    FDA Class 1 ·Immunology

    SPQ(TM) TEST SYSTEM FOR MICROALBUMIN

    FDA 510(k)
    FDA Class 1 ·Immunology
    View all

    Other Clearances by Hyland Therapeutic Div., Travenol Laboratories

    K Number Device Name
    K820835 ALUMINA SILICA-ACTIVATED PARTIAL THROM
    K820192 HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM
    K812220 NEPHELOMETRIC SOLID TURBIDITY STANDARD
    K810078 Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S
    K810077 OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.
    K802610 ALERT A,HDL-APOLIPOROTEIN A, TEST KIT
    K791113 LOW IONIC STRENGTH SOLUTION (LISS)
    K790249 TEST CELLS
    K781225 GLOBULIN TEST, HUMAN THYROXINE BINDING
    K780962 AUTOMATED ENZYME
    Search all 44 clearances from Hyland Therapeutic Div., Travenol Laboratories →