ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM— 510(k) K000903

Name: FDA 510(k) clearance K000903
Creator: U.S. Food and Drug Administration
Published: 2000-05-18

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K000903 for ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM, Substantially Equivalent on 2000-05-18. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code KLT
Device class: Class 2
Regulation: 21 CFR 862.3645
Advisory panel: Clinical Toxicology
Date received: 2000-03-21
Decision date: 2000-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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