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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: 11/12/2003
Date Received: 11/24/2003
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
Manufacturer: JENNIFER TRIBBETT
Device Classification Name: Reagent, Occult Blood
Regulation Number: KHE
Classification Product Code: 11/12/2003
Date Received: 11/24/2003
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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