FDA 510(k)

GSP Neonatal Total Galactose kit

Número K: K190335 · 2019-11-06

Data da decisão2019-11-06

Código do produtoJIA

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

GSP Neonatal Total Galactose kit is the device name listed in this FDA 510(k) record. The listed applicant is Perkinelmer, Inc.. It received FDA 510(k) clearance on 2019-11-06 under 510(k) number K190335. The device is classified under product code JIA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GSP Neonatal Total Galactose kit?

GSP Neonatal Total Galactose kit is a medical device that received FDA 510(k) clearance on 2019-11-06. The listed applicant is Perkinelmer, Inc.. The 510(k) number is K190335.

When did GSP Neonatal Total Galactose kit receive FDA 510(k) clearance?

GSP Neonatal Total Galactose kit received FDA 510(k) clearance on 2019-11-06, under 510(k) number K190335.

Who is the listed applicant for GSP Neonatal Total Galactose kit?

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

What is the FDA product code for GSP Neonatal Total Galactose kit?

The FDA product code for GSP Neonatal Total Galactose kit is JIA.

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Fonte oficial

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