FDA PMA

テスト、成人および小児用尿素（呼吸）

PMA番号：P100025 · 2020-05-26

申請者Meridian Bioscience, Inc.

決定日2020-05-26

PMA番号P100025

製品コードOZA

デバイスクラスクラス3

診療科M

規制番号21 CFR 8

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- MI --- URLや識別子などは原文のままです。

医療機器の概要

Test, urea adult and pediatric (breath), is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2020-05-26. The device is classified under product code OZA. It was reviewed by the MI advisory panel.

よくある質問

What is the Test, urea adult and pediatric (breath),?

Test, urea adult and pediatric (breath), is a medical device that received FDA 510(k) clearance on 2020-05-26. The listed applicant is Meridian Bioscience, Inc..

When did Test, urea adult and pediatric (breath), receive FDA 510(k) clearance?

The clearance date for Test, urea adult and pediatric (breath), can be found in the official FDA records.

Who is the listed applicant for Test, urea adult and pediatric (breath),?

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

What is the FDA product code for Test, urea adult and pediatric (breath),?

The FDA product code for Test, urea adult and pediatric (breath), is OZA.

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。

医療機器の概要

よくある質問

関連する臨床試験

公式ソース