ELECSYS PROBNP IMMUNOASSAY— 510(k) K022516

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K022516 for ELECSYS PROBNP IMMUNOASSAY, Substantially Equivalent on 2002-11-19. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code NBC
Advisory panel: Clinical Chemistry
Date received: 2002-07-30
Decision date: 2002-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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