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

    QMS AMIKACIN REAGENTS

    K Number: K052815 · Decision Nov 1, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    19
    Applicant Total
    28
    Review Days
    28

    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
    QMS AMIKACIN REAGENTS
    K Number
    K052815
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3035
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seradyn, Inc.
    Date Received
    October 4, 2005
    Decision Date
    November 1, 2005
    Product Code
    KLQ
    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
    KLQ Radioimmunoassay, Amikacin

    Similar 510(k) Clearances

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

    RANDOX AMIKACIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INNOFLUOR AMIKACIN ASSAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INNOFLUOR (TM) AMIKACIN REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    FPR AMIKACIN KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AMIKACIN ANALYTICAL TEST PACK ACA

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

    Other Clearances by Seradyn, Inc.

    K Number Device Name
    K070645 SERADYN QMS TOPIRAMATE
    K062966 QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS
    K062204 ARCHITECT CORTISOL ASSAY
    K060998 QMS TOBRAMYCIN
    K060709 MULTIGENT GENTAMICIN
    K052826 QMS QUINIDINE. QMS QUINIDINE CALIBRATORS
    K051211 QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS
    K050419 QMS VANCOMYCIN
    K042307 ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)
    K033674 MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
    Search all 28 clearances from Seradyn, Inc. →