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510(k) K962247

HICHEM CK/NAC REAGENT KIT by Elan Pharma, Inc. — Product Code CGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1996
Date Received
June 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

Other clearances by Elan Pharma, Inc.

  • K982469 — HICHEM CHOLESTEROL REAGENT KIT (August 19, 1998)
  • K981769 — HICHEM PHOSPHORUS REAGENT KIT (June 29, 1998)
  • K960115 — HICHEM BUN/UREA REAGENT KIT (March 29, 1996)

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