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510(k) K092113

STA - FREE PS CALIBRATOR by Diagnostica Stago, Inc. — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2009
Date Received
July 14, 2009
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

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  • K151867 — STA R MAX (August 7, 2015)
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  • K120014 — STA- COAG CONTROL (N+ABN) PLUS (March 14, 2013)
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  • K092937 — STA-HYBRID HEP CALIBRATOR (August 2, 2010)
  • K092170 — STA LIATEST FREE PS (December 22, 2009)
  • K093167 — STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER (December 22, 2009)

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