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FDA 510(k)

EasyLyte Na/K/Cl/Ca Analyzer

K-Number: K152327 · 2016-12-01

ApplicantMedica Corporation
Decision Date2016-12-01
Product CodeJFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EasyLyte Na/K/Cl/Ca Analyzer is a medical device manufactured by Medica Corporation. It received FDA 510(k) clearance on 2016-12-01 under approval number K152327. The device is classified under product code JFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EasyLyte Na/K/Cl/Ca Analyzer?

EasyLyte Na/K/Cl/Ca Analyzer is a medical device that received FDA 510(k) clearance on 2016-12-01. It is manufactured by Medica Corporation. The 510(k) number is K152327.

When was EasyLyte Na/K/Cl/Ca Analyzer approved by the FDA?

EasyLyte Na/K/Cl/Ca Analyzer received FDA 510(k) clearance on 2016-12-01, under approval number K152327.

What company makes EasyLyte Na/K/Cl/Ca Analyzer?

EasyLyte Na/K/Cl/Ca Analyzer is manufactured by Medica Corporation.

What is the FDA product code for EasyLyte Na/K/Cl/Ca Analyzer?

The FDA product code for EasyLyte Na/K/Cl/Ca Analyzer is JFP.

Other Devices by Medica Corporation

K220396EasyStat 300 K211559EasyStat 300 K220328EasyStat 300

Related Devices (Code: JFP)

K191626Stat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical Corporation K191360i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. K230300i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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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