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FDA 510(k), K132031, AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
FDA 510(k), K132031, AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
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510(K) Number: K132031
Device Name: AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
Manufacturer: KARI SKINNEMOEN
Device Classification Name: Enzymatic Esterase--Oxidase, Cholesterol
Regulation Number: CHH
Classification Product Code: 07/18/2013
Date Received: 03/21/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
Manufacturer: KARI SKINNEMOEN
Device Classification Name: Enzymatic Esterase--Oxidase, Cholesterol
Regulation Number: CHH
Classification Product Code: 07/18/2013
Date Received: 03/21/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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- Delivery: Approximately 1 to 2 weeks
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