FDA 510(k)

BacT/ALERT VIRTUO 미생물 검출 시스템, BacT/ALERT VIRTUO, VIRTUO

K-번호: K161816 · 2017-03-28

결정일2017-03-28

제품 코드MDB

자문 위원회MI

결정Substantially Equivalent

기기 요약

BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2017-03-28 under 510(k) number K161816. 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 BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO?

BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO is a medical device that received FDA 510(k) clearance on 2017-03-28. The listed applicant is bioMerieux, Inc.. The 510(k) number is K161816.

When did BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO receive FDA 510(k) clearance?

BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO received FDA 510(k) clearance on 2017-03-28, under 510(k) number K161816.

Who is the listed applicant for BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO?

The FDA 510(k) record lists bioMerieux, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO?

The FDA product code for BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO is MDB.

bioMerieux, Inc.를 신청인으로 등재한 기타 기록

K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST System K260282VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)K234012VITEK COMPACT PRO K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)

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