WIESLAB CAP PR-3 ANCA— 510(k) K051458

Substantially Equivalent

Eurodiagnostica

FDA 510(k) clearance K051458 for WIESLAB CAP PR-3 ANCA, Substantially Equivalent on 2005-11-22. Applicant: Eurodiagnostica. Device class: 2.

Clearance details

Applicant
Eurodiagnostica
Product code
Code MOB
Device class
Class 2
Regulation
21 CFR 866.5660
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Frederick, MD, US
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