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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 the device name listed in this FDA 510(k) record. The listed applicant is Awareness Technology, Inc.. It received FDA 510(k) clearance on 2018-02-27 under 510(k) 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. The listed applicant is Awareness Technology, Inc.. The 510(k) number is K171476.

When did SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) receive FDA 510(k) clearance?

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

Who is the listed applicant for SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)?

The FDA 510(k) record lists Awareness Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: JGS)

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.

K252475ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc.K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K213486GLP systems TrackAbbott LaboratoriesK200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation

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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