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

    TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU

    K Number: K854392 · Decision Dec 5, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    9
    Applicant Total
    19
    Review Days
    35

    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
    TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU
    K Number
    K854392
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Windsor Laboratories, Inc.
    Date Received
    October 31, 1985
    Decision Date
    December 5, 1985
    Product Code
    LFW
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LFW Fluorescence Polarization Immunoassay, Tobramycin

    Similar 510(k) Clearances

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

    ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AXSYM TOBRAMYCIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CEDIA(R) TOBRAMYCIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    FPR TOBRAMYCIN KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology
    View all

    Other Clearances by Windsor Laboratories, Inc.

    K Number Device Name
    K873281 CARBAMAZEPINE (FPIA) CALIBRATOR KIT
    K873282 CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY
    K871486 (FPIA) ASSAY BUFFER
    K870389 DIGOXIN (FPIA) CALIBRATOR KIT
    K870390 PHENOBARBITAL (FPIA) CALIBRATOR KIT
    K864333 DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY
    K863625 PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT
    K863244 AMIKACIN (FPIA) CALIBRATOR KIT
    K862248 AMIKACIN KIT (FPIA)
    K861770 PHENYTOIN (FPIA) CALIBRATOR KIT
    Search all 19 clearances from Windsor Laboratories, Inc. →