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510(k) K850390

CHOLESTEROL TEST SYSTEM by Hans J. Brouwers & Assoc. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1985
Date Received
February 1, 1985
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

Other clearances by Hans J. Brouwers & Assoc.

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