DeviceClearance

ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB— 510(k) K080092

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K080092 for ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB, Substantially Equivalent on 2008-07-28. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant
Roche Diagnostics Corp.
Product code
Code JZO
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Indianapolis, IN, US
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