CONE-TROL LIQUID CHEMISTRY CONTROLS— 510(k) K121759

Name: FDA 510(k) clearance K121759
Creator: U.S. Food and Drug Administration
Published: 2012-07-24

Substantially Equivalent

Cone Bioproducts

FDA 510(k) clearance K121759 for CONE-TROL LIQUID CHEMISTRY CONTROLS, Substantially Equivalent on 2012-07-24. Applicant: Cone Bioproducts. Device class: 1.

Clearance details

Applicant: Cone Bioproducts
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2012-06-15
Decision date: 2012-07-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Seguin, TX, US

Download summary PDF View on FDA.gov ↗

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