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510(k) K871260

CHOLESTEROL DETERMINATION by Biochemical Trade, Inc. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1987
Date Received
March 31, 1987
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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