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510(k) K030621

ATAC CALIBRATOR by Elan Diagnostics — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2003
Date Received
February 27, 2003
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 Diagnostics

  • K030003 — ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR (September 29, 2003)
  • K030014 — ATAC TOTAL BILIRUBIN REAGENT (September 26, 2003)
  • K023105 — ATAC CALCIUM REAGENT AND ATAC CALIBRATOR (March 13, 2003)
  • K030010 — ATAC PAK MAGNESIUM REAGENT (March 10, 2003)
  • K030015 — ATAC PAK PHOSPHORUS REAGENT (March 7, 2003)
  • K030006 — ATAC PAK ALBUMIN REAGENT (March 7, 2003)
  • K023407 — ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR (February 14, 2003)
  • K021385 — ATAC PAK BUN REAGENT (July 12, 2002)
  • K020575 — ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS (April 12, 2002)
  • K002285 — ATAC PAK ALP REAGENT KIT (September 26, 2000)

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  • K123321 — DIMENSION CHEMISTRY III CALIBRATORY (February 15, 2013)
  • K123372 — ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR (January 14, 2013)
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