FDA 510(k)

BD BACTEC Peds Plus/F 文化試管大豆酪蛋白消化湯含膠體於塑膠試管中

K 號：K173873 · 2018-03-16

決定日期2018-03-16

產品代碼MDB

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2018-03-16 under 510(k) number K173873. The device is classified under product code MDB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial?

BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial is a medical device that received FDA 510(k) clearance on 2018-03-16. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K173873.

When did BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial receive FDA 510(k) clearance?

BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial received FDA 510(k) clearance on 2018-03-16, under 510(k) number K173873.

Who is the listed applicant for BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial?

The FDA product code for BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial is MDB.

其他以 Becton, Dickinson and Company 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262163BD BBL穆勒-金頓II培養基（陽離子調整）；BD Difco穆勒-金頓培養基 K260128BD Preset™ 和 BD A-Line™ 动脈血液採集針筒 K252506BD Vacutainer® 安全鎖™ 採血套組; BD Vacutainer® 安全鎖™ 採血套組配預裝持桿器 K252378BD® MiniDraw™ 微量血採集系統配BD® MiniDraw™ SST™ 微量血採集管 K260184Onclarity™ 自取樣套件 K252040BD Vacutainer® 血漿分離管 (PST™), BD Vacutainer® 钠鹽肝素採血管

查看所有 102 項裝置 →

相關器械（代碼：MDB）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260213BD BACTEC FXI 培養系統BD Diagnostic Systems K222559BD BACTEC™ Myco/F 溶菌文化試管Becton, Dickinson and Company K222591BD BACTEC™ Plus 需氧/培養試管Becton, Dickinson and Company K190405BACT/ALERT MP試劑系統bioMerieux, Inc.K183166BacT/ALERT FA Plus；BacT/ALERT PF PlusbioMerieux, Inc.K161816BacT/ALERT VIRTUO 微生物檢測系統，BacT/ALERT VIRTUO，VIRTUObioMerieux, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。