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

    CRYPTO-LEX SYSTEM

    K Number: K930418 · Decision Feb 17, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    9
    Applicant Total
    44
    Review Days
    387

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    Basic Information

    Device Name
    CRYPTO-LEX SYSTEM
    K Number
    K930418
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3165
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Trinity Laboratories, Inc.
    Date Received
    January 26, 1993
    Decision Date
    February 17, 1994
    Product Code
    GMD
    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
    GMD Antisera, Latex Agglutination, Cryptococcus Neoformans

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    K970722 EYE TRAY
    K965201 O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE
    K964921 BASIC BIOPSY TRAY. DISPOSABLE, STERILE
    K953929 MID-STREAM COLLECTION SET-STERILE
    K952058 STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE
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