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

    TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL)

    K Number: K884747 · Decision Jan 30, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    157
    Review Days
    77

    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
    TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL)
    K Number
    K884747
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Technicon Instruments Corp.
    Date Received
    November 14, 1988
    Decision Date
    January 30, 1989
    Product Code
    CKB
    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
    CKB Acid Phosphatase, Naphthyl Phosphate

    Similar 510(k) Clearances

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

    DRI-STAT ACID PHOSPHATASE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OLYMPUS ACID PHOSPHATASE REAGENT

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

    Other Clearances by Technicon Instruments Corp.

    K Number Device Name
    K914511 TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL
    K914888 TECHNICON CHEM 1(TM) SYST (GEN2 SYST)
    K914025 TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)
    K912616 TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES
    K912413 CHEM-LINK DATA BASE MANAGER
    K903825 DRUG OF ABUSE ANALYSIS SYSTEM
    K903305 TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD
    K903824 DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY
    K903306 TECHNICON CHEM I SYSTEM MAGNESIUM METHOD
    K901410 TECHNICON RA-2000(TM) SYSTEM
    Search all 157 clearances from Technicon Instruments Corp. →