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. Device class: 2.

Clearance details

Applicant: Roche Diagnostics GmbH
Product code: Code LOJ
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1998-04-08
Decision date: 1998-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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