ELECSYS TESTOSTERONE CALSET II— 510(k) K003411

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K003411 for ELECSYS TESTOSTERONE CALSET II, Substantially Equivalent on 2001-03-01. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JIT
Advisory panel: Clinical Chemistry
Date received: 2000-11-02
Decision date: 2001-03-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Indianapolis, IN, US

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