ELECSYS CA 15-3 TEST SYSTEM— 510(k) K001468

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K001468 for ELECSYS CA 15-3 TEST SYSTEM, Substantially Equivalent on 2000-10-23. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code MOI
Advisory panel: Immunology
Date received: 2000-05-10
Decision date: 2000-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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