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FDA 510(k)

MYCOLOGY CULTURE SYSTEM

K-Number: K802946 · 1980-12-22

ApplicantOrion Diagnostica, Inc.
Decision Date1980-12-22
Product CodeJSJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MYCOLOGY CULTURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orion Diagnostica, Inc.. It received FDA 510(k) clearance on 1980-12-22 under 510(k) number K802946. 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 MYCOLOGY CULTURE SYSTEM?

MYCOLOGY CULTURE SYSTEM is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is Orion Diagnostica, Inc.. The 510(k) number is K802946.

When did MYCOLOGY CULTURE SYSTEM receive FDA 510(k) clearance?

MYCOLOGY CULTURE SYSTEM received FDA 510(k) clearance on 1980-12-22, under 510(k) number K802946.

Who is the listed applicant for MYCOLOGY CULTURE SYSTEM?

The FDA 510(k) record lists Orion Diagnostica, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MYCOLOGY CULTURE SYSTEM?

The FDA product code for MYCOLOGY CULTURE SYSTEM 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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