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FDA 510(k)

FLOUROSET IMMUNOFLUORESCENT ANTIBODY

K-Number: K823055 · 1982-11-05

ApplicantImmulok, Inc.
Decision Date1982-11-05
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FLOUROSET IMMUNOFLUORESCENT ANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is Immulok, Inc.. It received FDA 510(k) clearance on 1982-11-05 under 510(k) number K823055. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOUROSET IMMUNOFLUORESCENT ANTIBODY?

FLOUROSET IMMUNOFLUORESCENT ANTIBODY is a medical device that received FDA 510(k) clearance on 1982-11-05. The listed applicant is Immulok, Inc.. The 510(k) number is K823055.

When did FLOUROSET IMMUNOFLUORESCENT ANTIBODY receive FDA 510(k) clearance?

FLOUROSET IMMUNOFLUORESCENT ANTIBODY received FDA 510(k) clearance on 1982-11-05, under 510(k) number K823055.

Who is the listed applicant for FLOUROSET IMMUNOFLUORESCENT ANTIBODY?

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

What is the FDA product code for FLOUROSET IMMUNOFLUORESCENT ANTIBODY?

The FDA product code for FLOUROSET IMMUNOFLUORESCENT ANTIBODY is DHN.

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Other records listing Immulok, Inc. as applicant

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Related Devices (Code: DHN)

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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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