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FDA 510(k)

BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO

K-Number: K161816 · 2017-03-28

ApplicantbioMerieux, Inc.
Decision Date2017-03-28
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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Related Devices (Code: MDB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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