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

    PROSPECT CRYPTOSPORIDIUM RAPID ASSAY

    K Number: K936191 · Decision Nov 17, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    14
    Applicant Total
    5
    Review Days
    329

    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
    PROSPECT CRYPTOSPORIDIUM RAPID ASSAY
    K Number
    K936191
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3220
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alexon Biomedical, Inc.
    Date Received
    December 23, 1993
    Decision Date
    November 17, 1994
    Product Code
    MHJ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MHJ Cryptosporidium Spp.

    Similar 510(k) Clearances

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

    TRI-COMBO PARASITE SCREEN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    UNI-GOLD CRYPTOSPORIDIUM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GIARDIA/CRYPTOSPORIDIUM CHEK

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CRYPTOSPORIDIUM II

    FDA 510(k)
    FDA Class 2 ·Microbiology

    XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020

    FDA 510(k)
    FDA Class 2 ·Microbiology

    IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Alexon Biomedical, Inc.

    K Number Device Name
    K964864 PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY
    K955157 PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY
    K933997 PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY
    K874849 PROSPECT/GIARDIA