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FDA 510(k)

BacT/ALERT FA Plus; BacT/ALERT PF Plus

K-Number: K183166 · 2019-02-11

ApplicantbioMerieux, Inc.
Decision Date2019-02-11
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BacT/ALERT FA Plus; BacT/ALERT PF Plus is a medical device manufactured by bioMerieux, Inc.. It received FDA 510(k) clearance on 2019-02-11 under approval number K183166. 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 FA Plus; BacT/ALERT PF Plus?

BacT/ALERT FA Plus; BacT/ALERT PF Plus is a medical device that received FDA 510(k) clearance on 2019-02-11. It is manufactured by bioMerieux, Inc.. The 510(k) number is K183166.

When was BacT/ALERT FA Plus; BacT/ALERT PF Plus approved by the FDA?

BacT/ALERT FA Plus; BacT/ALERT PF Plus received FDA 510(k) clearance on 2019-02-11, under approval number K183166.

What company makes BacT/ALERT FA Plus; BacT/ALERT PF Plus?

BacT/ALERT FA Plus; BacT/ALERT PF Plus is manufactured by bioMerieux, Inc..

What is the FDA product code for BacT/ALERT FA Plus; BacT/ALERT PF Plus?

The FDA product code for BacT/ALERT FA Plus; BacT/ALERT PF Plus is MDB.

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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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