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

    IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES

    K Number: K980646 · Decision May 6, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    16
    Applicant Total
    321
    Review Days
    76

    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
    IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES
    K Number
    K980646
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1113
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumentation Laboratory CO
    Date Received
    February 19, 1998
    Decision Date
    May 6, 1998
    Product Code
    MQM
    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
    MQM Bilirubin (Total And Unbound) In The Neonate Test System

    Similar 510(k) Clearances

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

    ABL90 FLEX, ABL90 FLEX PLUS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DRAEGER JAUNDICE METER JM-105

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ABL90 FLEX

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RAPIDPOINT 405 NEONATAL BILIRUBIN

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    JAUNDICE METER, MODEL JM 103

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Instrumentation Laboratory CO

    K Number Device Name
    K221359 ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM
    K223187 HemosIL Liquid Anti-Xa
    K223090 GEM Premier ChemSTAT
    K223402 HemosIL von Willebrand Factor Antigen
    K213464 HemosIL Liquid Anti-Xa
    K213426 HemosIL ReadiPlasTin
    K203790 GEM Premier 5000
    DEN190032 HemosIL Liquid Anti-Xa
    K200033 HemosIL von Willebrand Factor Antigen
    K183549 GEM Premier ChemSTAT
    Search all 321 clearances from Instrumentation Laboratory CO →