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

    CARDIAC CARE Q/C TEST KIT

    K Number: K782033 · Decision Dec 15, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    18
    Applicant Total
    321
    Review Days
    9

    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
    CARDIAC CARE Q/C TEST KIT
    K Number
    K782033
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5325
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Instrumentation Laboratory CO
    Date Received
    December 6, 1978
    Decision Date
    December 15, 1978
    Product Code
    DRL
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DRL Tester, Defibrillator

    Similar 510(k) Clearances

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

    Delta 3300

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UniPulse

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Defibrillator Analyzer Variable Load

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEFIBRILLATOR ANALYZER - DA-2006P

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMPULSE 6000D/7000DP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Instrumentation Laboratory CO

    K Number Device Name
    K221359 ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM
    K223187 HemosIL Liquid Anti-Xa
    K223090 GEM Premier ChemSTAT
    K223402 HemosIL von Willebrand Factor Antigen
    K213464 HemosIL Liquid Anti-Xa
    K213426 HemosIL ReadiPlasTin
    K203790 GEM Premier 5000
    DEN190032 HemosIL Liquid Anti-Xa
    K200033 HemosIL von Willebrand Factor Antigen
    K183549 GEM Premier ChemSTAT
    Search all 321 clearances from Instrumentation Laboratory CO →