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510(k) K896073

CHOLESTEROL, UNIVERSAL ET by Enzyme Technology, Inc. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1989
Date Received
October 19, 1989
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 Enzyme Technology, Inc.

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  • K905227 — GLUCOSE (HK) REAGENT, UNIVERSAL (March 11, 1991)
  • K905226 — TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL (December 11, 1990)

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