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

    ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS

    K Number: K973535 · Decision Oct 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    55
    Applicant Total
    24
    Review Days
    32

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    Basic Information

    Device Name
    ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS
    K Number
    K973535
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3645
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Schiapparelli Biosystems, Inc.
    Date Received
    September 18, 1997
    Decision Date
    October 20, 1997
    Product Code
    KLT
    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
    KLT Enzyme Immunoassay, Carbamazepine

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    Other Clearances by Schiapparelli Biosystems, Inc.

    K Number Device Name
    K991733 ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS
    K981377 ACE T4 REAGENT T4 CALIBRATORS
    K981375 ACE T UPTAKE REAGENT TU CALIBRATORS
    K973581 ACE VALPROIC ACID REAGENT, AED CALIBRATORS
    K973583 ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS
    K973582 ACE PRIMIDONE REAGENT, AED CALIBRATORS
    K973536 ACE PHENOBARBITAL REAGENT/AED CALIBRATORS
    K973414 ACE PHENYTOIN REAGENT, AED CALIBRATORS
    K971526 ACE HDL-C REAGENT
    K954179 HDL PRECIPITATING REAGENT
    Search all 24 clearances from Schiapparelli Biosystems, Inc. →