DeviceClearance

ELECSYS AFP— 510(k) K981282

Substantially Equivalent

Roche Diagnostics GmbH

FDA 510(k) clearance K981282 for ELECSYS AFP, Substantially Equivalent on 1998-05-01. Applicant: Roche Diagnostics GmbH.

Clearance details

Applicant
Roche Diagnostics GmbH
Product code
Code LOJ
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pleasanton, CA, US
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