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510(k) K982469

HICHEM CHOLESTEROL REAGENT KIT by Elan Pharma, Inc. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1998
Date Received
July 15, 1998
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 Elan Pharma, Inc.

  • K981769 — HICHEM PHOSPHORUS REAGENT KIT (June 29, 1998)
  • K962247 — HICHEM CK/NAC REAGENT KIT (August 15, 1996)
  • K960115 — HICHEM BUN/UREA REAGENT KIT (March 29, 1996)

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