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

    SYSTEMATE A AMYLASE HEM 67204

    K Number: K843645 · Decision Sep 28, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    30
    Applicant Total
    288
    Review Days
    11

    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
    SYSTEMATE A AMYLASE HEM 67204
    K Number
    K843645
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    September 17, 1984
    Decision Date
    September 28, 1984
    Product Code
    CIJ
    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
    CIJ Saccharogenic, Amylase

    Similar 510(k) Clearances

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

    AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AMYLASE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AMYLASE (ETHYLIDENE PNGPG7) KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LIQUID AMYLASE (CNPG3) REAGENT SET

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

    Other Clearances by Em Diagnostic Systems, Inc.

    K Number Device Name
    K935181 ASPARTATE AMINOTRANSFERASE (AST) TEST
    K935180 ALANINE AMINOTRANSFERASE (ALT) TEST
    K935178 EMDS PHOSPHOROUS (PHOS) TEST
    K935179 EMDS ALBUMIN (ALB) TEST
    K935174 TOTAL PROTEIN TEST (TPRO)
    K935177 GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
    K935136 CHOLESTEROL (CHOL) TEST ITEM NO. 65410
    K935175 LACTATE DEHYDROGENASE (LD)
    K935176 IRON TEST
    K935183 EMDS MAGNESIUM (MG) TEST
    Search all 288 clearances from Em Diagnostic Systems, Inc. →