VARELISA PR3 ANCA, MODEL NUMBER 17748/17796— 510(k) K041043

Name: FDA 510(k) clearance K041043
Creator: U.S. Food and Drug Administration
Published: 2004-07-02

Substantially Equivalent

Pharmacia Deutschland GmbH

FDA 510(k) clearance K041043 for VARELISA PR3 ANCA, MODEL NUMBER 17748/17796, Substantially Equivalent on 2004-07-02. Applicant: Pharmacia Deutschland GmbH. Device class: 2.

Clearance details

Applicant: Pharmacia Deutschland GmbH
Product code: Code MOB
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2004-04-22
Decision date: 2004-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freiburg Im Breisgau, DE

Download summary PDF View on FDA.gov ↗

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