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