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FDA 510(k)

MYCOBIOTIC AGAR

K-Number: K830069 · 1983-02-09

ApplicantbioMerieux, Inc.
Decision Date1983-02-09
Product CodeJSJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MYCOBIOTIC 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 1983-02-09 under 510(k) number K830069. The device is classified under product code JSJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYCOBIOTIC AGAR?

MYCOBIOTIC AGAR is a medical device that received FDA 510(k) clearance on 1983-02-09. The listed applicant is bioMerieux, Inc.. The 510(k) number is K830069.

When did MYCOBIOTIC AGAR receive FDA 510(k) clearance?

MYCOBIOTIC AGAR received FDA 510(k) clearance on 1983-02-09, under 510(k) number K830069.

Who is the listed applicant for MYCOBIOTIC 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 MYCOBIOTIC AGAR?

The FDA product code for MYCOBIOTIC AGAR is JSJ.

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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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