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FDA 510(k)

BACT/ALERT MP CULTURE BOTTLES (PLASTIC)

K-Number: K031737 · 2003-07-14

ApplicantbioMerieux, Inc.
Decision Date2003-07-14
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACT/ALERT MP CULTURE BOTTLES (PLASTIC) is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2003-07-14 under 510(k) number K031737. 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 MP CULTURE BOTTLES (PLASTIC)?

BACT/ALERT MP CULTURE BOTTLES (PLASTIC) is a medical device that received FDA 510(k) clearance on 2003-07-14. The listed applicant is bioMerieux, Inc.. The 510(k) number is K031737.

When did BACT/ALERT MP CULTURE BOTTLES (PLASTIC) receive FDA 510(k) clearance?

BACT/ALERT MP CULTURE BOTTLES (PLASTIC) received FDA 510(k) clearance on 2003-07-14, under 510(k) number K031737.

Who is the listed applicant for BACT/ALERT MP CULTURE BOTTLES (PLASTIC)?

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 MP CULTURE BOTTLES (PLASTIC)?

The FDA product code for BACT/ALERT MP CULTURE BOTTLES (PLASTIC) 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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