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FDA 510(k)

MDA B.30

K-Number: K050513 · 2005-04-01

ApplicantbioMerieux, Inc.
Decision Date2005-04-01
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MDA B.30 is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2005-04-01 under 510(k) number K050513. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MDA B.30?

MDA B.30 is a medical device that received FDA 510(k) clearance on 2005-04-01. The listed applicant is bioMerieux, Inc.. The 510(k) number is K050513.

When did MDA B.30 receive FDA 510(k) clearance?

MDA B.30 received FDA 510(k) clearance on 2005-04-01, under 510(k) number K050513.

Who is the listed applicant for MDA B.30?

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 MDA B.30?

The FDA product code for MDA B.30 is JPA.

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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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