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510(k) K992845

HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT by Elan Holdings, Inc. — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1999
Date Received
August 24, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
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)
  • K012474 — ATAC PAK CPK REAGENT KIT (October 3, 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)
  • K992842 — HICHEM ISE ELECTROLYTE REFERENCE (November 26, 1999)
  • K992844 — HICHEM ISE ELECTROLYTE BUFFER (November 26, 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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