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510(k) K110394

ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) by Vital Diagnostics (Manufacturing) Ptyltd — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2011
Date Received
February 11, 2011
Clearance Type
Abbreviated
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 Vital Diagnostics (Manufacturing) Ptyltd

  • K120626 — EON CALCIUM REGENT (August 22, 2012)
  • K112416 — CPK REAGENT (November 9, 2011)
  • K111063 — VITAL SERUM CONTROLS (June 28, 2011)
  • K100060 — EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77 (December 15, 2010)

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  • K123321 — DIMENSION CHEMISTRY III CALIBRATORY (February 15, 2013)
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