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FDA 510(k)

PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER

K-Number: K012987 · 2001-11-07

ApplicantPhoenix Diagnostics, Inc.
Decision Date2001-11-07
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER 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 2001-11-07 under 510(k) number K012987. 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 ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER?

PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER is a medical device that received FDA 510(k) clearance on 2001-11-07. The listed applicant is Phoenix Diagnostics, Inc.. The 510(k) number is K012987.

When did PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER receive FDA 510(k) clearance?

PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER received FDA 510(k) clearance on 2001-11-07, under 510(k) number K012987.

Who is the listed applicant for PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER?

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 ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER?

The FDA product code for PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER is JIX.

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Other records listing Phoenix Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K023268PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMSK020364PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMSK020148pHoenix ISE Reagents FOR Olympus AU Chemistry SystemsK020129PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULEK013451PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIESK012509PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM

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Related Devices (Code: JIX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 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.

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