FDA 510(k)

pHoenix ISE Reagents FOR Olympus AU Chemistry Systems

K-Number: K020148 · 2002-02-04

Decision Date2002-02-04

Product CodeCGZ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

pHoenix ISE Reagents FOR Olympus AU Chemistry Systems 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 2002-02-04 under 510(k) number K020148. The device is classified under product code CGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the pHoenix ISE Reagents FOR Olympus AU Chemistry Systems?

pHoenix ISE Reagents FOR Olympus AU Chemistry Systems is a medical device that received FDA 510(k) clearance on 2002-02-04. The listed applicant is Phoenix Diagnostics, Inc.. The 510(k) number is K020148.

When did pHoenix ISE Reagents FOR Olympus AU Chemistry Systems receive FDA 510(k) clearance?

pHoenix ISE Reagents FOR Olympus AU Chemistry Systems received FDA 510(k) clearance on 2002-02-04, under 510(k) number K020148.

Who is the listed applicant for pHoenix ISE Reagents FOR Olympus AU Chemistry Systems?

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 ISE Reagents FOR Olympus AU Chemistry Systems?

The FDA product code for pHoenix ISE Reagents FOR Olympus AU Chemistry Systems is CGZ.

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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 K020129PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE 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: CGZ)

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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.