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

    BETA-CELL

    K Number: K791607 · Decision Sep 24, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    208
    Applicant Total
    9
    Review Days
    41

    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
    BETA-CELL
    K Number
    K791607
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2300
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Biologics Intl., Inc.
    Date Received
    August 14, 1979
    Decision Date
    September 24, 1979
    Product Code
    JSG
    Advisory Committee
    Microbiology
    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
    JSG Culture Media, Non-Selective And Non-Differential

    Similar 510(k) Clearances

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

    THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007

    FDA 510(k)
    FDA Class 1 ·Microbiology

    LETHEEN AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    HEART INFUSION AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    GELATIN

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SKIM MILK DEHYDRATED

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DEXTROSE TRYPTONE BROTH

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    Other Clearances by Biologics Intl., Inc.

    K Number Device Name
    K882229 AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS
    K823353 CARCINO-CEK
    K812060 BI-ASO SLIDE TEST
    K811374 BI-CRP LATEX TEST
    K811375 BI-RA SLIDE TEST
    K800605 ANA LATEX SLIDE TEST
    K791609 BE-SURE
    K790898 PREG-TEX