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

    STC AUTO-LYTE URINARY GLUCOSE ASSAY

    K Number: K962435 · Decision Dec 26, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    144
    Applicant Total
    30
    Review Days
    185

    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
    STC AUTO-LYTE URINARY GLUCOSE ASSAY
    K Number
    K962435
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    OraSure Technologies, Inc.
    Date Received
    June 24, 1996
    Decision Date
    December 26, 1996
    Product Code
    CFR
    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
    CFR Hexokinase, Glucose

    Similar 510(k) Clearances

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

    Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Glucose2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II

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

    Other Clearances by OraSure Technologies, Inc.

    K Number Device Name
    DEN190025 OraQuick Ebola Rapid Antigen Test
    K060859 COMPOUND W FREEZE OFF WART REMOVAL SYSTEM
    K023487 HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
    K013882 OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
    K020371 UPLINK TEST SYSTEM
    K011057 INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
    K002375 STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
    K001976 STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
    K002010 STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
    K000399 STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
    Search all 30 clearances from OraSure Technologies, Inc. →