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

    DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY

    K Number: K760883 · Decision Nov 19, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    9
    Applicant Total
    24
    Review Days
    29

    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
    DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY
    K Number
    K760883
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Nuclear Medical Laboratories, Inc.
    Date Received
    October 21, 1976
    Decision Date
    November 19, 1976
    Product Code
    DPB
    Advisory Committee
    Clinical Toxicology
    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
    DPB Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.

    Similar 510(k) Clearances

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

    OPTIMATE DIGOXIN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DIGOXIN KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    125I DIGOXIN RADIOIMMUNOASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DIGOXIN RADIOIMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DIGOXIN RADIOIMMUNOASSAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    RIA, DIGNXIN-125-I

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology
    View all

    Other Clearances by Nuclear Medical Laboratories, Inc.

    K Number Device Name
    K852438 NML TSH IRMA
    K844583 TSH-STAT
    K840466 NML CORTISOL RIA
    K840589 TRI-TUBE RIA
    K832892 MODIFIED CHORIO-SHURE
    K832002 NML-5010/5020 MULTI-DETECTOR SYSTEM
    K823679 NML 6000 CT
    K823053 NML-TETRA-TUBE RIA
    K822298 DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI
    K820523 CHORIO-QUANT
    Search all 24 clearances from Nuclear Medical Laboratories, Inc. →