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510(k) K871676

ENZYMATIC CHOLESTEROL REAGENT SET by Michclone Associates, Inc. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1987
Date Received
April 28, 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

Other clearances by Michclone Associates, Inc.

  • K860812 — SICKLE CELL REAGENT SET (April 11, 1986)
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