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510(k) K111063

VITAL SERUM CONTROLS by Vital Diagnostics (Manufacturing) Ptyltd — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2011
Date Received
April 18, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
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)
  • K110394 — ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) (June 9, 2011)
  • K100060 — EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77 (December 15, 2010)

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