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

    EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS

    K Number: K955448 · Decision Feb 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    6
    Applicant Total
    145
    Review Days
    86

    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
    EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS
    K Number
    K955448
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3580
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Behring Diagnostics, Inc.
    Date Received
    November 29, 1995
    Decision Date
    February 23, 1996
    Product Code
    DLB
    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
    DLB Radioimmunoassay, Lsd (125-I)

    Similar 510(k) Clearances

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

    ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CEDIA DAU LSD ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    STC DIAGNOSTICS LSD MICRO-PLATE EIA

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    REVISED LABELING FOR LSD TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD

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

    Other Clearances by Behring Diagnostics, Inc.

    K Number Device Name
    K973832 OPUS HLH CONTROLS
    K972929 N ANTISERUM TO HUMAN ALBUMIN
    K972840 N ANTISERUM TO HUMAN TRANSFERRIN
    K973202 MODIFICATION OF OPUS FERRITIN TEST SYSTEM
    K972316 OPUS D-DIMER
    K972116 VON WILLEBRAND REAGENT
    K972011 OPUS ETHANOL
    K971600 EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)
    K971596 EMIT II OPIATES 300/2000 ASSAY
    K964595 OPUS PSA TEST SYSTEM
    Search all 145 clearances from Behring Diagnostics, Inc. →