ELECSYS HCG STAT CLASET II— 510(k) K003941

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K003941 for ELECSYS HCG STAT CLASET II, Substantially Equivalent on 2001-01-25. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JIS
Advisory panel: Clinical Chemistry
Date received: 2000-12-21
Decision date: 2001-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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