ADVIA 1650 CHOLINESTERASE ASSAY— 510(k) K013750

Name: FDA 510(k) clearance K013750
Creator: U.S. Food and Drug Administration
Published: 2002-01-18

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K013750 for ADVIA 1650 CHOLINESTERASE ASSAY, Substantially Equivalent on 2002-01-18. Applicant: Bayer Diagnostics Corp.. Device class: 1.

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code DIH
Device class: Class 1
Regulation: 21 CFR 862.3240
Advisory panel: Clinical Toxicology
Date received: 2001-11-13
Decision date: 2002-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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