FDA 510(k)

Eonis SCID-SMA 套件

K号: K203035 · 2022-11-09

决定日期2022-11-09

产品代码PJI

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器械摘要

Eonis SCID-SMA 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 2022-11-09 under 510(k) number K203035. The device is classified under product code PJI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Eonis SCID-SMA kit?

Eonis SCID-SMA kit is a medical device that received FDA 510(k) clearance on 2022-11-09. The listed applicant is Perkinelmer, Inc.. The 510(k) number is K203035.

When did Eonis SCID-SMA kit receive FDA 510(k) clearance?

Eonis SCID-SMA kit received FDA 510(k) clearance on 2022-11-09, under 510(k) number K203035.

Who is the listed applicant for Eonis SCID-SMA 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 Eonis SCID-SMA kit?

The FDA product code for Eonis SCID-SMA kit is PJI.

列明Perkinelmer, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K193103NeoBase 2 非衍生物 MSMS 试剂盒 K190335GSP Neonatal Total Galactose kit 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

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列明Perkinelmer, Inc.为申报人的其他记录

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