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

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

    K Number: K072142 · Decision Jun 26, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    21
    Review Days
    329

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    Basic Information

    Device Name
    S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST
    K Number
    K072142
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alfa Wassermann Diagnostic Technologies, Inc.
    Date Received
    August 2, 2007
    Decision Date
    June 26, 2008
    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

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    K122757 ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
    K113389 ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
    K113437 ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT
    K113374 ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT
    K113262 ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT
    K113438 ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
    K113253 ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT
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