FDA 510(k)

GSP Neonatal Total Galactose kit

K号: K190335 · 2019-11-06

决定日期2019-11-06

产品代码JIA

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决定实质等同

器械摘要

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.

常见问题

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.

列明Perkinelmer, Inc.为申报人的其他记录

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K203035Eonis SCID-SMA 套件 K193103NeoBase 2 非衍生物 MSMS 试剂盒 K190266NeoLSD MSMS 试剂盒 K161966PerkinElmer XRpad2 4336 HWC-M 平板探测器 K161942PerkinElmer, XRpad2 3025 HWC-M 平板探测器

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器械摘要

常见问题

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列明Perkinelmer, Inc.为申报人的其他记录

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