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FDA 510(k)

SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)

K-Number: K171476 · 2018-02-27

ApplicantAwareness Technology, Inc.
Decision Date2018-02-27
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) is a medical device manufactured by Awareness Technology, Inc.. It received FDA 510(k) clearance on 2018-02-27 under approval number K171476. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)?

SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) is a medical device that received FDA 510(k) clearance on 2018-02-27. It is manufactured by Awareness Technology, Inc.. The 510(k) number is K171476.

When was SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) approved by the FDA?

SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) received FDA 510(k) clearance on 2018-02-27, under approval number K171476.

What company makes SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)?

SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) is manufactured by Awareness Technology, Inc..

What is the FDA product code for SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)?

The FDA product code for SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) is JGS.

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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.

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