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FDA 510(k)

LA-SPORO ANTIBODY SYSTEM

K-Number: K802427 · 1980-10-31

ApplicantImmuno-Mycologics, Inc.
Decision Date1980-10-31
Product CodeGMA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LA-SPORO ANTIBODY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Immuno-Mycologics, Inc.. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K802427. The device is classified under product code GMA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LA-SPORO ANTIBODY SYSTEM?

LA-SPORO ANTIBODY SYSTEM is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Immuno-Mycologics, Inc.. The 510(k) number is K802427.

When did LA-SPORO ANTIBODY SYSTEM receive FDA 510(k) clearance?

LA-SPORO ANTIBODY SYSTEM received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802427.

Who is the listed applicant for LA-SPORO ANTIBODY SYSTEM?

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

What is the FDA product code for LA-SPORO ANTIBODY SYSTEM?

The FDA product code for LA-SPORO ANTIBODY SYSTEM is GMA.

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Other records listing Immuno-Mycologics, Inc. as applicant

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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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