URISYS 2400 URINE TEST STRIP— 510(k) K012397

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K012397 for URISYS 2400 URINE TEST STRIP, Substantially Equivalent on 2001-09-26. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JIL
Advisory panel: Clinical Chemistry
Date received: 2001-07-27
Decision date: 2001-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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