FDA 510(k)

Diazyme PLAC® 测定Lp-PLA2活性

K号: K203136 · 2021-08-06

决定日期2021-08-06

产品代码NOE

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决定实质等同

器械摘要

Diazyme PLAC® Test for Lp-PLA2 Activity is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories, Inc.. It received FDA 510(k) clearance on 2021-08-06 under 510(k) number K203136. The device is classified under product code NOE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Diazyme PLAC® Test for Lp-PLA2 Activity?

Diazyme PLAC® Test for Lp-PLA2 Activity is a medical device that received FDA 510(k) clearance on 2021-08-06. The listed applicant is Diazyme Laboratories, Inc.. The 510(k) number is K203136.

When did Diazyme PLAC® Test for Lp-PLA2 Activity receive FDA 510(k) clearance?

Diazyme PLAC® Test for Lp-PLA2 Activity received FDA 510(k) clearance on 2021-08-06, under 510(k) number K203136.

Who is the listed applicant for Diazyme PLAC® Test for Lp-PLA2 Activity?

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

What is the FDA product code for Diazyme PLAC® Test for Lp-PLA2 Activity?

The FDA product code for Diazyme PLAC® Test for Lp-PLA2 Activity is NOE.

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器械摘要

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列明Diazyme Laboratories, Inc.为申报人的其他记录

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