CO2 CALIBRATOR/DILUENT— 510(k) K033643

Name: FDA 510(k) clearance K033643
Creator: U.S. Food and Drug Administration
Published: 2004-01-08

Substantially Equivalent

Bayer Healthcare, Diagnostics Division

FDA 510(k) clearance K033643 for CO2 CALIBRATOR/DILUENT, Substantially Equivalent on 2004-01-08. Applicant: Bayer Healthcare, Diagnostics Division. Device class: 2.

Clearance details

Applicant: Bayer Healthcare, Diagnostics Division
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2003-11-20
Decision date: 2004-01-08
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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