ARCHITECT SIROLIMUS ASSAY— 510(k) K070822

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K070822 for ARCHITECT SIROLIMUS ASSAY, Substantially Equivalent on 2007-09-28. Applicant: Fujirebio Diagnostics,Inc..

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code NRP
Advisory panel: Clinical Toxicology
Date received: 2007-03-26
Decision date: 2007-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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