FDA 510(k)

BD BACTEC Standard/10 好氧/F 文化試管大豆酪蛋白消化湯於塑膠試管中

K 號：K161810 · 2017-02-09

決定日期2017-02-09

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 Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson. It received FDA 510(k) clearance on 2017-02-09 under 510(k) number K161810. 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 Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial?

BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial is a medical device that received FDA 510(k) clearance on 2017-02-09. The listed applicant is Becton Dickinson. The 510(k) number is K161810.

When did BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial receive FDA 510(k) clearance?

BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial received FDA 510(k) clearance on 2017-02-09, under 510(k) number K161810.

Who is the listed applicant for BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial?

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

What is the FDA product code for BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial?

The FDA product code for BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial is MDB.

其他以 Becton Dickinson 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。

K243062BD Intelliport 系統; BD Intelliport 閱讀器 (516230); BD Intelliport 感應器 (516229); BD Intelliport 網關 (516232); BD Intelliport 裝置 (516233); BD Intelliport 充電器 (516231)K161306BD BACTEC Standard Anaerobic/F 文化試管大豆酪蛋白消化湯於塑膠試管中

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 K222591BD BACTEC™ Plus 需氧/培養試管Becton, Dickinson and Company K222559BD BACTEC™ Myco/F 溶菌文化試管Becton, Dickinson and Company K190405BACT/ALERT MP試劑系統bioMerieux, Inc.K183166BacT/ALERT FA Plus；BacT/ALERT PF PlusbioMerieux, Inc.K173873BD 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Becton, Dickinson and Company

官方來源

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