N ANTISERA TO HUMAN CERULOPLASMIN— 510(k) K053074

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K053074 for N ANTISERA TO HUMAN CERULOPLASMIN, Substantially Equivalent on 2006-03-16. Applicant: Dade Behring, Inc.. Device class: 2.

Clearance details

Applicant
Dade Behring, Inc.
Product code
Code DDB
Device class
Class 2
Regulation
21 CFR 866.5210
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Newark, DE, US
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