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

    CALCIUM STANDARD, ITEM #65075

    K Number: K822473 · Decision Sep 17, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    129
    Applicant Total
    62
    Review Days
    31

    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
    CALCIUM STANDARD, ITEM #65075
    K Number
    K822473
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Emd Chemicals, Inc.
    Date Received
    August 17, 1982
    Decision Date
    September 17, 1982
    Product Code
    JIS
    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
    JIS Calibrator, Primary

    Similar 510(k) Clearances

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

    DIRECT LDL/HDL CHOLESTEROL CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION IRON CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER

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

    Other Clearances by Emd Chemicals, Inc.

    K Number Device Name
    K031367 DUOPATH VEROTOXINS GLISA TEST
    K990516 ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
    K981926 ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
    K973054 ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
    K951494 AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)
    K951750 GLUCOSE TEST ITEM NUMBER 97375/94
    K950234 TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2
    K950128 TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2
    K945322 PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416
    K945368 PHOSPHORUS TEST (PHOS)
    Search all 62 clearances from Emd Chemicals, Inc. →