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510(k) K120202

EON CHOLESTEROL REAGENT by Vital Diagnostics Pty., Ltd. — Product Code CHH

K120202 is an FDA 510(k) premarket notification submitted by Vital Diagnostics Pty., Ltd. for the device "EON CHOLESTEROL REAGENT". The FDA issued a decision of Substantially Equivalent on July 27, 2012. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2012
Date Received
January 23, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Esterase--Oxidase, Cholesterol
Device Class
Class I
Regulation Number
862.1175
Review Panel
CH
Submission Type

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FDA data resources