ARCHITECT BNP ASSAY, MODEL 8K28— 510(k) K060964

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K060964 for ARCHITECT BNP ASSAY, MODEL 8K28, Substantially Equivalent on 2006-05-25. Applicant: Fujirebio Diagnostics,Inc..

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code NBC
Advisory panel: Clinical Chemistry
Date received: 2006-04-07
Decision date: 2006-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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