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

    EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)

    K Number: K971600 · Decision Jun 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    93
    Applicant Total
    145
    Review Days
    55

    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 CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)
    K Number
    K971600
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Behring Diagnostics, Inc.
    Date Received
    May 1, 1997
    Decision Date
    June 25, 1997
    Product Code
    DKB
    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
    DKB Calibrators, Drug Mixture

    Similar 510(k) Clearances

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

    COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    RANDOX METHAMPHETAMINE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190

    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
    K971596 EMIT II OPIATES 300/2000 ASSAY
    K964595 OPUS PSA TEST SYSTEM
    K971725 OPUS PROGESTERONE
    Search all 145 clearances from Behring Diagnostics, Inc. →