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

    REP ALKALINE HB-15 #3196,-8 #3197,-4 3198

    K Number: K931465 · Decision Jul 6, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    280
    Review Days
    104

    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
    REP ALKALINE HB-15 #3196,-8 #3197,-4 3198
    K Number
    K931465
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7440
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Helena Laboratories
    Date Received
    March 24, 1993
    Decision Date
    July 6, 1993
    Product Code
    JBD
    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
    JBD System, Analysis, Electrophoretic Hemoglobin

    Similar 510(k) Clearances

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

    MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACID HEMOGLOBIN KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)

    FDA 510(k)
    FDA Class 2 ·Hematology

    SPIFE ALKALINE HEMOGLOBIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)

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

    Other Clearances by Helena Laboratories

    K Number Device Name
    K131479 V8 SP NORMAL CONTROL, ABNORMAL CONTROL
    K100103 SPECIALTY ASSAYED CONTROL-2
    K061991 PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
    K061069 SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458
    K061014 ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
    K050053 HEMORAM/AGGRAM ANALYZER
    K024162 SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
    K023761 PLATELETWORKS, MODELS PW-A, PW-C
    K022757 SPIFE CK KIT, MODEL 3332, 3333
    K022455 SPIFE LD-12 KIT, MODEL 3338
    Search all 280 clearances from Helena Laboratories →