MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C— 510(k) K003120

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K003120 for MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C, Substantially Equivalent on 2000-12-18. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2000-10-05
Decision date: 2000-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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