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

    TRYPSIN RIA KIT

    K Number: K861097 · Decision May 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    6
    Applicant Total
    8
    Review Days
    66

    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
    TRYPSIN RIA KIT
    K Number
    K861097
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1725
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Microanalytic Research, Inc.
    Date Received
    March 24, 1986
    Decision Date
    May 29, 1986
    Product Code
    JNO
    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
    JNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin

    Similar 510(k) Clearances

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

    AUTODELFIA NEONATAL IRT KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GSP NEONATAL IRT KIT (3306-001U)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MRI NEO-TRYP TRYPSIN RIA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TRYPIN (125I) RIA KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RIA KIT FOR TRYPSIN

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

    Other Clearances by Microanalytic Research, Inc.

    K Number Device Name
    K820741 MR1 LUTROPIN RIA KIT
    K820740 MR1 FOLLITROPIN RIA KIT
    K813516 MRI TOBRAMYCIN RIA KIT
    K812394 MRI GENTAMICIN RIA KIT
    K810949 MRI PROLACTIN RIA KIT
    K802754 IMMUNOREACTIVE ESTRIOL RIA KIT
    K801491 MRI HCG-BETA RIA KIT CAT. #MR-10100