ENZYGNOST F+2 (MONOCLONAL) TEST KIT— 510(k) K042687

Name: FDA 510(k) clearance K042687
Creator: U.S. Food and Drug Administration
Published: 2004-12-10

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K042687 for ENZYGNOST F+2 (MONOCLONAL) TEST KIT, Substantially Equivalent on 2004-12-10. Applicant: Dade Behring, Inc.. Device class: 2.

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code MIF
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 2004-09-29
Decision date: 2004-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

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