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510(k) K023268

PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS by Phoenix Diagnostics, Inc. — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2002
Date Received
September 30, 2002
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 Phoenix Diagnostics, Inc.

  • K020364 — PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS (June 4, 2002)
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  • K020129 — PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE (February 1, 2002)
  • K013451 — PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES (December 18, 2001)
  • K012987 — PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER (November 7, 2001)
  • K012509 — PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMI (October 9, 2001)
  • K960592 — ELECTROLYTE STANDARDS (May 13, 1996)
  • K945860 — SPECTRUM CO-OXIMETER LINEARITY CONTROL (January 17, 1995)
  • K920285 — BLOOD GAS/ISE LINEARITY CONTROL (July 14, 1992)
  • K912718 — ENZYME LINEARITY CONTROL (September 6, 1991)

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