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510(k) K012474

ATAC PAK CPK REAGENT KIT by Elan Holdings, Inc. — Product Code CGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2001
Date Received
August 2, 2001
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 Holdings, Inc.

  • K013152 — ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS (November 9, 2001)
  • K010488 — ATAC PAK AST REAGENT KIT (April 9, 2001)
  • K000958 — ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS (May 24, 2000)
  • K000900 — ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS (May 2, 2000)
  • K992844 — HICHEM ISE ELECTROLYTE BUFFER (November 26, 1999)
  • K992842 — HICHEM ISE ELECTROLYTE REFERENCE (November 26, 1999)
  • K992845 — HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIB (October 18, 1999)
  • K992846 — HICHEM TOTAL PROTEIN REAGENT (October 18, 1999)
  • K992847 — HICHEM BUN REAGENT (October 14, 1999)
  • K991789 — ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (July 9, 1999)

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