VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896— 510(k) K023433

Name: FDA 510(k) clearance K023433
Creator: U.S. Food and Drug Administration
Published: 2002-11-13

Substantially Equivalent

Pharmacia Diagnostics GmbH & Co. KG

FDA 510(k) clearance K023433 for VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896, Substantially Equivalent on 2002-11-13. Applicant: Pharmacia Diagnostics GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Pharmacia Diagnostics GmbH & Co. KG
Product code: Code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2002-10-15
Decision date: 2002-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freiburg, DE

Download summary PDF View on FDA.gov ↗

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