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FDA 510(k)

BACT/ALERT FA PLUS CULTURE BOTTLE

K-Number: K121461 · 2013-01-22

ApplicantbioMerieux, Inc.
Decision Date2013-01-22
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACT/ALERT FA PLUS CULTURE BOTTLE is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2013-01-22 under 510(k) number K121461. 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 CULTURE BOTTLE?

BACT/ALERT FA PLUS CULTURE BOTTLE is a medical device that received FDA 510(k) clearance on 2013-01-22. The listed applicant is bioMerieux, Inc.. The 510(k) number is K121461.

When did BACT/ALERT FA PLUS CULTURE BOTTLE receive FDA 510(k) clearance?

BACT/ALERT FA PLUS CULTURE BOTTLE received FDA 510(k) clearance on 2013-01-22, under 510(k) number K121461.

Who is the listed applicant for BACT/ALERT FA PLUS CULTURE BOTTLE?

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 FA PLUS CULTURE BOTTLE?

The FDA product code for BACT/ALERT FA PLUS CULTURE BOTTLE is MDB.

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Related Devices (Code: 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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