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

Name: FDA 510(k) clearance K023840
Creator: U.S. Food and Drug Administration
Published: 2003-01-07

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.. Device class: 2.

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code CKB
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 2002-11-18
Decision date: 2003-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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