FDA 510(k)

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

K-Nummer: K171476 · 2018-02-27

Entscheidungsdatum2018-02-27

ProduktcodeJGS

BeratungsausschussCH

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Verwandte Geräte (Code: JGS)

K252475ABL90 FLEX PLUS SystemRadiometer Medicals Aps K230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K222438A-LYTE® Integriertes 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 Laboratories K200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation

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