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FDA 510(k)

Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer

N.º K: K171971 · 2018-01-25

SolicitanteLite-On Technology Corp. H.S.P.B.
Fecha de decisión2018-01-25
Código de productoCJE
Comité asesorCH
DecisiónSubstantially Equivalent

Resumen del dispositivo

Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Lite-On Technology Corp. H.S.P.B.. It received FDA 510(k) clearance on 2018-01-25 under 510(k) number K171971. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer?

Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer is a medical device that received FDA 510(k) clearance on 2018-01-25. The listed applicant is Lite-On Technology Corp. H.S.P.B.. The 510(k) number is K171971.

When did Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer receive FDA 510(k) clearance?

Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer received FDA 510(k) clearance on 2018-01-25, under 510(k) number K171971.

Who is the listed applicant for Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer?

The FDA 510(k) record lists Lite-On Technology Corp. H.S.P.B. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer?

The FDA product code for Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer is CJE.

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Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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