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

    LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN

    K Number: K944325 · Decision Feb 22, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    26
    Applicant Total
    72
    Review Days
    173

    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
    LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN
    K Number
    K944325
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Princeton BioMeditech Corp.
    Date Received
    September 2, 1994
    Decision Date
    February 22, 1995
    Product Code
    JHW
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JHW U.V. Method, Cpk Isoenzymes

    Similar 510(k) Clearances

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

    Creatine Kinase-MB

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELITECH CLINICAL SYSTEMS CK NAC SL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ROCHE DIAGNOSTICS CK-MB

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELECSYS CK-MB

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

    Other Clearances by Princeton BioMeditech Corp.

    K Number Device Name
    K251538 Status™ COVID-19/Flu A&B
    K182157 BioSign Flu A+B
    K130650 STATUS DS OXY
    K133474 BIOSIGN FLU A + B, STATUS FLU A & B
    K132465 BIOSIGN FLU A + B, STATUS FLU A & B
    K083746 BIOSIGN FLU A+B
    K100817 BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
    K100341 SPERMCHECK FERTILITY
    K082661 BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A
    K073039 SPERMCHECK VASECTOMY
    Search all 72 clearances from Princeton BioMeditech Corp. →