ADVIA TESTPOINT CSF CONTROL— 510(k) K022968

Name: FDA 510(k) clearance K022968
Creator: U.S. Food and Drug Administration
Published: 2002-09-24

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K022968 for ADVIA TESTPOINT CSF CONTROL, Substantially Equivalent on 2002-09-24. Applicant: Bayer Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 2002-09-06
Decision date: 2002-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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