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

    ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES

    K Number: K853198 · Decision Oct 4, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    180
    Applicant Total
    14
    Review Days
    66

    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
    ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES
    K Number
    K853198
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Medical Device Consultants, Inc.
    Date Received
    July 30, 1985
    Decision Date
    October 4, 1985
    Product Code
    JPA
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JPA System, Multipurpose For In Vitro Coagulation Studies

    Similar 510(k) Clearances

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

    STA Satellite Max®

    FDA 510(k)
    FDA Class 2 ·Hematology

    Automated Blood Coagulation Analyzer CN-Series (CN-6000)

    FDA 510(k)
    FDA Class 2 ·Hematology

    TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

    FDA 510(k)
    FDA Class 2 ·Hematology

    TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

    FDA 510(k)
    FDA Class 2 ·Hematology

    Citrated: K, KH, RTH, FFH

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACL TOP 970 CL

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

    Other Clearances by Medical Device Consultants, Inc.

    K Number Device Name
    K022895 ELCAM STOPCOCKS AND MANIFOLDS
    K002699 PARIETEX COMPOSITE (PCO) MESH
    K002116 S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0
    K000551 IMAGE X-70 PLUS DENTAL X-RAY UNIT
    K974164 SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE
    K864282 GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA
    K860122 HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME
    K860932 ULTRASUN 1000 & 2000 SUNTANNING UNIT
    K860929 ULTRASUN 4000 FT & 15000-8 SUNTANNING UNIT
    K860931 ULTRASUN 3000 AND 5000 SUNTANNING UNIT
    Search all 14 clearances from Medical Device Consultants, Inc. →