FDA 510(k)

ETEST 피퍼아실린/타조바캄 (P/T) (0.016/4-256/4 µg/mL)

K-번호: K190154 · 2019-05-01

결정일2019-05-01

제품 코드JWY

자문 위원회미 (Original text: MI)

결정대체적으로 동일

기기 요약

ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux S.A.. It received FDA 510(k) clearance on 2019-05-01 under 510(k) number K190154. 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 ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)?

ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) is a medical device that received FDA 510(k) clearance on 2019-05-01. The listed applicant is Biomerieux S.A.. The 510(k) number is K190154.

When did ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) receive FDA 510(k) clearance?

ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) received FDA 510(k) clearance on 2019-05-01, under 510(k) number K190154.

Who is the listed applicant for ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)?

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

What is the FDA product code for ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)?

The FDA product code for ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) is JWY.

Biomerieux S.A.를 신청인으로 등재한 기타 기록

K250274ETEST 이미펜ем/리레바کتام P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)K210757ETEST 포스포모이신 (FO) (0.032-512 µg/mL)K192738ETEST Delafloxacin (DFX) (0.002-32 µg/mL)K192050ETEST 에라바사이클린 (ERV) (0.002 – 32 µg/mL)K191953ETEST 이미펜ем/리레바کت람 (IPR) (0.002/4-32/4 µg/mL)K183031ETEST 메로펜엠/바보르바카마 (MEV) (0.004/8-64/8 µg/mL)

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