DeviceClearance

ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET— 510(k) K050231

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K050231 for ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET, Substantially Equivalent on 2005-07-06. Applicant: Roche Diagnostics Corp..

Clearance details

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