FDA 510(k)

BD BACTEC 페즈 플러스/에이치 문화 액체 병 소이아스-케이신 디지스트 브로스와 플라스틱 병에 있는 레진

K-번호: K173873 · 2018-03-16

결정일2018-03-16

제품 코드MDB

자문 위원회미 (Original text: MI)

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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.

Becton, Dickinson and Company를 신청인으로 등재한 기타 기록

K262163BD BBL Mueller Hinton II 용액 (양이온 조정형); BD Difco Mueller Hinton 용액 K260128BD Preset™ 및 BD A-Line™ 동맥 혈액 수집 주사기 K252506BD Vacutainer® 안전-락™ 혈액 수집 세트; BD Vacutainer® 안전-락™ 혈액 수집 세트 및 사전 연결된 홀더 K252378BD® 미니드로우™ 세포질 혈액 수집 시스템 및 BD® 미니드로우™ SST™ 세포질 혈액 수집 튜브 K260184온클리어티™ 자가수집 키트 K252040BD Vacutainer® 피라미드 분리 튜브 (PST™), BD Vacutainer® 나트륨 헤파린 혈액 수집 튜브

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