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510(k) K946063

TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL by Cholestech Corp. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1995
Date Received
November 15, 1994
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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  • K932727 — CHOLESTECH L.D.X. SYSTEM (November 9, 1993)

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