VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996— 510(k) K040450

Name: FDA 510(k) clearance K040450
Creator: U.S. Food and Drug Administration
Published: 2004-05-11

Substantially Equivalent

Pharmacia Deutschland GmbH

FDA 510(k) clearance K040450 for VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996, Substantially Equivalent on 2004-05-11. Applicant: Pharmacia Deutschland GmbH. Device class: 2.

Clearance details

Applicant: Pharmacia Deutschland GmbH
Product code: Code MSV
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2004-02-20
Decision date: 2004-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freiburg, DE

Download summary PDF View on FDA.gov ↗

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