ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD— 510(k) K022331

Name: FDA 510(k) clearance K022331
Creator: U.S. Food and Drug Administration
Published: 2002-09-11

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K022331 for ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD, Substantially Equivalent on 2002-09-11. Applicant: Bayer Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 2002-07-18
Decision date: 2002-09-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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