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

    AMYLASE

    K Number: K930678 · Decision Apr 6, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    98
    Applicant Total
    7
    Review Days
    421

    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
    AMYLASE
    K Number
    K930678
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Horizon Diagnostics, Inc.
    Date Received
    February 9, 1993
    Decision Date
    April 6, 1994
    Product Code
    JFJ
    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
    JFJ Catalytic Methods, Amylase

    Similar 510(k) Clearances

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

    Amylase2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Atellica CH Amylase_2 (AMY_2)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607

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

    Other Clearances by Horizon Diagnostics, Inc.

    K Number Device Name
    K971566 CREATINE KINASE-MB REAGENT SET
    K933722 HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT
    K935712 IRON/TIBC REAGENT
    K934533 BUN-300/BUN-500 UREA NITROGEN REAGENT
    K930679 DIRECT BILIRUBIN
    K930074 IN-VITRO DIAGNOSTIC REAGENT SET