BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent for Some Indications 🇺🇸 United States

    YSI MODEL 1500 SPORT L-LACTATE ANALYZER

    K Number: K901131 · Decision Aug 27, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    26
    Applicant Total
    23
    Review Days
    168

    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
    YSI MODEL 1500 SPORT L-LACTATE ANALYZER
    K Number
    K901131
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1450
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Yellow Springs Instrument Co., Inc.
    Date Received
    March 12, 1990
    Decision Date
    August 27, 1990
    Product Code
    KHP
    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
    KHP Acid, Lactic, Enzymatic Method

    Similar 510(k) Clearances

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

    PICCOLO LACTATE TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RAPIDPOINT 500 BLOOD GAS ANALYER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Yellow Springs Instrument Co., Inc.

    K Number Device Name
    K962070 YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE
    K922821 YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES
    K922007 YSI MODEL 441A AIRWAY TEMPERATURE PROBE
    K910633 YSI MODEL 1500 BLOOD GLUCOSE ANALYZER
    K910718 YSI PRECISION 4000 THERMOMETER
    K893409 YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP
    K891480 YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER
    K883793 DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS)
    K865012 YSI MODEL 801
    K853551 YSI MODEL 790 TELE-THERMOMETER
    Search all 23 clearances from Yellow Springs Instrument Co., Inc. →