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

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

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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)

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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