DIMENSION HAIC ASSAY, MODEL DF105— 510(k) K011852

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K011852 for DIMENSION HAIC ASSAY, MODEL DF105, Substantially Equivalent on 2001-11-15. Applicant: Dade Behring, Inc..

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2001-06-12
Decision date: 2001-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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