FDA 510(k)

MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL

K-번호: K211672 · 2021-10-20

결정일2021-10-20

제품 코드JWY

자문 위원회MI

결정Substantially Equivalent

기기 요약

MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL is the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem s.r.l.. It received FDA 510(k) clearance on 2021-10-20 under 510(k) number K211672. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL?

MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL is a medical device that received FDA 510(k) clearance on 2021-10-20. The listed applicant is Liofilchem s.r.l.. The 510(k) number is K211672.

When did MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL receive FDA 510(k) clearance?

MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL received FDA 510(k) clearance on 2021-10-20, under 510(k) number K211672.

Who is the listed applicant for MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL?

The FDA 510(k) record lists Liofilchem s.r.l. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL?

The FDA product code for MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL is JWY.

Liofilchem s.r.l.를 신청인으로 등재한 기타 기록

K260696MTS Gepotidacin 0.016-256 µg/mL K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL K251580MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)K243202MTS Ceftobiprole 0.002-32 µg/mL K230479ComASP Cefiderocol 0.008-128 K200180MTS Omadacycline 0.002 - 32 ug/mL

35개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.