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

    HICHEM ALP/AMP REAGENT KIT

    K Number: K963383 · Decision Sep 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    41
    Review Days
    27

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    Basic Information

    Device Name
    HICHEM ALP/AMP REAGENT KIT
    K Number
    K963383
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hichem Diagnostics
    Date Received
    August 27, 1996
    Decision Date
    September 23, 1996
    Product Code
    CKF
    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
    CKF Phenylphosphate, Alkaline Phosphatase Or Isoenzymes

    Similar 510(k) Clearances

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

    S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
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    Other Clearances by Hichem Diagnostics

    K Number Device Name
    K981794 HICHEM CALCIUM REAGENT KIT
    K953862 HICHEM ISEKCI SOLUTION KIT 70010
    K953860 HICHEM ISE DILUENT KIT 70008
    K953861 HICHEM ISE INTDERNAL REFERENCE KIT 70009
    K953863 HICHEM ISE STANDARDS KIT 70011
    K951751 HICHEM AST REAGENT KIT
    K946192 HICHEM Y-GT REAGENT KIT
    K946022 HICHEM LDH/L REAGENT KIT
    K941433 HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH
    K925612 HI CHEM ELECTROLYTE BUFFER
    Search all 41 clearances from Hichem Diagnostics →