ATAC PAK BUN REAGENT— 510(k) K021385

Substantially Equivalent

Elan Diagnostics

FDA 510(k) clearance K021385 for ATAC PAK BUN REAGENT, Substantially Equivalent on 2002-07-12. Applicant: Elan Diagnostics.

Clearance details

Applicant: Elan Diagnostics
Product code: Code CDQ
Advisory panel: Clinical Chemistry
Date received: 2002-05-02
Decision date: 2002-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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