FDA 510(k)

PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES

K-Number: K013451 · 2001-12-18

Decision Date2001-12-18

Product CodeCGZ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES 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 2001-12-18 under 510(k) number K013451. 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 PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES?

PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES is a medical device that received FDA 510(k) clearance on 2001-12-18. The listed applicant is Phoenix Diagnostics, Inc.. The 510(k) number is K013451.

When did PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES receive FDA 510(k) clearance?

PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES received FDA 510(k) clearance on 2001-12-18, under 510(k) number K013451.

Who is the listed applicant for PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES?

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 PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES?

The FDA product code for PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES 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 K020148pHoenix ISE Reagents FOR Olympus AU Chemistry Systems K020129PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE 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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Official Source

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