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510(k) K902095

BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS by Phoenix Diagnostics, Inc. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1990
Date Received
May 8, 1990
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 Phoenix Diagnostics, Inc.

  • K023268 — PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS (November 15, 2002)
  • K020364 — PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS (June 4, 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)

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  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K150300 — Liquichek Cardiac Markers Plus Control LT (December 11, 2015)
  • K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit (April 30, 2015)
  • K143379 — Liquichek Maternal Serum II Control (March 13, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)