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510(k) K020364

PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS by Phoenix Diagnostics, Inc. — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2002
Date Received
February 4, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type

Other clearances by Phoenix Diagnostics, Inc.

  • K023268 — PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS (November 15, 2002)
  • K020148 — pHoenix ISE Reagents FOR Olympus AU Chemistry Systems (February 4, 2002)
  • 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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