FDA 510(k)

PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE

K-Number: K020129 · 2002-02-01

Decision Date2002-02-01

Product CodeJIX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Diagnostics, Inc.. It received FDA 510(k) clearance on 2002-02-01 under 510(k) number K020129. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE?

PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE is a medical device that received FDA 510(k) clearance on 2002-02-01. The listed applicant is Phoenix Diagnostics, Inc.. The 510(k) number is K020129.

When did PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE receive FDA 510(k) clearance?

PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE received FDA 510(k) clearance on 2002-02-01, under 510(k) number K020129.

Who is the listed applicant for PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE?

The FDA 510(k) record lists Phoenix Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE?

The FDA product code for PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE is JIX.

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Other records listing Phoenix Diagnostics, Inc. as applicant

K023268PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS K020364PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS K020148pHoenix ISE Reagents FOR Olympus AU Chemistry Systems K013451PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES K012987PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER K012509PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM

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Related Devices (Code: JIX)

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche Diagnostics K130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroup K123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare Diagnostics K123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott Laboratories K122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.