ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650— 510(k) K023840

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K023840 for ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650, Substantially Equivalent on 2003-01-07. Applicant: Bayer Diagnostics Corp..

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code CKB
Advisory panel: Clinical Chemistry
Date received: 2002-11-18
Decision date: 2003-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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