ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER— 510(k) K033548

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K033548 for ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER, Substantially Equivalent on 2003-11-24. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code KHE
Advisory panel: Hematology
Date received: 2003-11-12
Decision date: 2003-11-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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