FDA 510(k)

Alinity m EBV (09N43-095)

K号: K243489 · 2025-07-28

决定日期2025-07-28

产品代码QLX

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决定实质等同

器械摘要

Alinity m EBV (09N43-095) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2025-07-28 under 510(k) number K243489. The device is classified under product code QLX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Alinity m EBV (09N43-095)?

Alinity m EBV (09N43-095) is a medical device that received FDA 510(k) clearance on 2025-07-28. The listed applicant is Abbott Molecular, Inc.. The 510(k) number is K243489.

When did Alinity m EBV (09N43-095) receive FDA 510(k) clearance?

Alinity m EBV (09N43-095) received FDA 510(k) clearance on 2025-07-28, under 510(k) number K243489.

Who is the listed applicant for Alinity m EBV (09N43-095)?

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

What is the FDA product code for Alinity m EBV (09N43-095)?

The FDA product code for Alinity m EBV (09N43-095) is QLX.

列明Abbott Molecular, 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。

K252102Alinity m HCV K243485Alinity m CMV K241921Alinity m BKV K241573Alinity m Resp-4-Plex K233349Alinity m HSV 1 & 2 / VZV K222379Alinity m STI Assay

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。