ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK— 510(k) K060755

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K060755 for ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK, Substantially Equivalent on 2006-04-10. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code CDD
Advisory panel: Clinical Chemistry
Date received: 2006-03-21
Decision date: 2006-04-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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