BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT

    K Number: K121101 · Decision Jun 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    9
    Review Days
    435

    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
    SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT
    K Number
    K121101
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1310
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Astoria-Pacific, Inc.
    Date Received
    April 11, 2012
    Decision Date
    June 20, 2013
    Product Code
    JIA
    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
    JIA Enzymatic Methods, Galactose

    Similar 510(k) Clearances

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

    GSP Neonatal Total Galactose kit

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GSP NEONATAL TOTAL GALACTOSE KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    QUANTASE TOTAL GALACTOSE SCREENING ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Astoria-Pacific, Inc.

    K Number Device Name
    K102643 SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
    K101392 NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D
    K090940 SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
    K080294 ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT
    K010844 ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K
    K990957 ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K
    K970093 TYROSINE 50-HOUR REAGENT KIT
    K970277 URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)