FDA 510(k)

Liofilchem MIC 테스트 스틱 (MTS)-반콤신 0.016 - 256 μg/mL

K-번호: K153687 · 2016-03-31

결정일2016-03-31

제품 코드JWY

자문 위원회미 (Original text: MI)

결정대체적으로 동일

기기 요약

Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/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 2016-03-31 under 510(k) number K153687. 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 Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL?

Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL is a medical device that received FDA 510(k) clearance on 2016-03-31. The listed applicant is Liofilchem s.r.l.. The 510(k) number is K153687.

When did Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL receive FDA 510(k) clearance?

Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL received FDA 510(k) clearance on 2016-03-31, under 510(k) number K153687.

Who is the listed applicant for Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/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 Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL?

The FDA product code for Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL is JWY.

Liofilchem s.r.l.를 신청인으로 등재한 기타 기록

K260696MTS 지포티딘 0.016-256 µg/mL K252114MTS 아즈트레온아박타마 0.016/4 - 256/4 µg/mL K251580MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)K243202MTS 세프토비프롤 0.002-32 µg/mL K230479ComASP 세피디로콜 0.008-128 K211672MTS 피퍼아실린-타조바쿰 0.016/4 - 256/4µg/mL

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