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FDA 510(k)

chromID Strepto B agar

K-Number: K163042 · 2017-01-27

ApplicantbioMerieux, Inc.
Decision Date2017-01-27
Product CodePQZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

chromID Strepto B agar is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2017-01-27 under 510(k) number K163042. The device is classified under product code PQZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the chromID Strepto B agar?

chromID Strepto B agar is a medical device that received FDA 510(k) clearance on 2017-01-27. The listed applicant is bioMerieux, Inc.. The 510(k) number is K163042.

When did chromID Strepto B agar receive FDA 510(k) clearance?

chromID Strepto B agar received FDA 510(k) clearance on 2017-01-27, under 510(k) number K163042.

Who is the listed applicant for chromID Strepto B agar?

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 chromID Strepto B agar?

The FDA product code for chromID Strepto B agar is PQZ.

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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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