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FDA 510(k)

ASPERGILLUS SP., ANTIGEN

K-Number: K792687 · 1980-01-17

ApplicantMeridian Diagnostics, Inc.
Decision Date1980-01-17
Product CodeJWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASPERGILLUS SP., ANTIGEN is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Diagnostics, Inc.. It received FDA 510(k) clearance on 1980-01-17 under 510(k) number K792687. The device is classified under product code JWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASPERGILLUS SP., ANTIGEN?

ASPERGILLUS SP., ANTIGEN is a medical device that received FDA 510(k) clearance on 1980-01-17. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K792687.

When did ASPERGILLUS SP., ANTIGEN receive FDA 510(k) clearance?

ASPERGILLUS SP., ANTIGEN received FDA 510(k) clearance on 1980-01-17, under 510(k) number K792687.

Who is the listed applicant for ASPERGILLUS SP., ANTIGEN?

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

What is the FDA product code for ASPERGILLUS SP., ANTIGEN?

The FDA product code for ASPERGILLUS SP., ANTIGEN is JWI.

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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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