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    FDA 510(k), K033548, ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER

    FDA 510(k), K033548, ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER

    $392.19 USD
    $392.19 USD
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    510(K) Number: K033548
    Device Name: ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
    Manufacturer: JENNIFER TRIBBETT
    Device Classification Name: Reagent, Occult Blood
    Regulation Number: KHE
    Classification Product Code: KXA
    Date Received: 11/12/2003
    Decision Date: 11/24/2003
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Clinical Chemistry

    • Total Pages: 184
    • Fully Redacted Pages: 39
    • Content Pages: 145 (total pages minus fully redacted pages)
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