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Phoenix Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K023268PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMSNovember 15, 2002
K020364PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMSJune 4, 2002
K020148pHoenix ISE Reagents FOR Olympus AU Chemistry SystemsFebruary 4, 2002
K020129PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULEFebruary 1, 2002
K013451PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIESDecember 18, 2001
K012987PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZERNovember 7, 2001
K012509PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEMOctober 9, 2001
K960592ELECTROLYTE STANDARDSMay 13, 1996
K945860SPECTRUM CO-OXIMETER LINEARITY CONTROLJanuary 17, 1995
K920285BLOOD GAS/ISE LINEARITY CONTROLJuly 14, 1992
K912718ENZYME LINEARITY CONTROLSeptember 6, 1991
K904075CLINICAL CHEMISTRY CONTROLDecember 6, 1990
K902675MULTI ANALYTE MIXTURE, CALIBRATORSJuly 31, 1990
K902616BILIRUBIN CONTROLJuly 19, 1990
K902094BLOOD GAS/ISE CONTROLSJuly 19, 1990
K902267BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTSJune 12, 1990
K902095BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLSJune 12, 1990
K902266ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)June 6, 1990
K901985BLOOD GAS CONTROLSJune 6, 1990
K901976BLOOD GAS/CO-OXIMETRY CONTROLMay 31, 1990