BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    SALICYLATE-SL ASSAY

    K Number: K042329 · Decision Dec 27, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    28
    Applicant Total
    66
    Review Days
    122

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    Basic Information

    Device Name
    SALICYLATE-SL ASSAY
    K Number
    K042329
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3830
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Chemicals , Ltd.
    Date Received
    August 27, 2004
    Decision Date
    December 27, 2004
    Product Code
    DKJ
    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
    DKJ Colorimetry, Salicylate

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    Other Clearances by Diagnostic Chemicals , Ltd.

    K Number Device Name
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    K060139 CRP-ADVANCE ASSAY, MODELS 250-20, 250-25
    K060140 CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250
    K051757 CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91
    K051191 DCL MICROALBUMIN ASSAY, MODEL 252-20
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    K042362 MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
    K041928 HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B
    K041926 HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278
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