DeviceClearance

ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP— 510(k) K081338

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K081338 for ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP, Substantially Equivalent on 2008-09-11. Applicant: Roche Diagnostics.

Clearance details

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