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

    METHANOL, ABSOLUTE

    K Number: K872189 · Decision Jul 29, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    39
    Applicant Total
    137
    Review Days
    51

    Basic Information

    Device Name
    METHANOL, ABSOLUTE
    K Number
    K872189
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    REMEL CO.
    Date Received
    June 8, 1987
    Decision Date
    July 29, 1987
    Product Code
    JTS
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JTS Stains, Microbiologic

    Similar 510(k) Clearances

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

    CALCOFLUOR WHITE STAIN KIT

    FDA 510(k)
    FDA Class 1 ·Hematology

    BACTIDROP CALCOFLUOR WHITE

    FDA 510(k)
    FDA Class 1 ·Hematology

    BACTIDROP INDIA INK

    FDA 510(k)
    FDA Class 1 ·Hematology

    BACTIDROP CALCOFLUOR WHITE

    FDA 510(k)
    FDA Class 1 ·Hematology

    BACTIDROP KOH (10%)

    FDA 510(k)
    FDA Class 1 ·Hematology

    IRISTAIN FORMULA 2, PARTS 1 AND 2

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

    Other Clearances by REMEL CO.

    K Number Device Name
    K013711 BACTI-SWAB DRY
    K965149 A.C.T. I
    K965151 A.C.T. III
    K965152 A.C.T. II
    K965150 A.C.T. IV
    K960090 CALCOFLUOR WHITE STAIN KIT
    K960095 BACTIDROP CALCOFLUOR WHITE
    K955669 REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK
    K941443 SYNERGY QUAD
    K941444 BHI AGAR WITH VANCOMYCIN
    Search all 137 clearances from REMEL CO. →