FDA 510(k)

BD BACTEC 표준 암모니아 배양/문화 액체 캔들 소이밀-케이신 분해 액체, 플라스틱 캔들

K-번호: K161306 · 2016-08-08

결정일2016-08-08

제품 코드MDB

자문 위원회MI

결정Substantially Equivalent

기기 요약

BD BACTEC Standard Anaerobic/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 2016-08-08 under 510(k) number K161306. The device is classified under product code MDB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial?

BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial is a medical device that received FDA 510(k) clearance on 2016-08-08. The listed applicant is Becton Dickinson. The 510(k) number is K161306.

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

BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial received FDA 510(k) clearance on 2016-08-08, under 510(k) number K161306.

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

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

Becton Dickinson를 신청인으로 등재한 기타 기록

K243062BD 인텔포트 시스템; BD 인텔포트 리더 (516230); BD 인텔포트 센서 (516229); BD 인텔포트 게이트웨이 (516232); BD 인텔포트 마운트 (516233); BD 인텔포트 충전기 (516231)K161810BD BACTEC 표준/10 표양/산소성 문화 액체 병 소이-케이신 분해 액체(플라스틱 병)

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