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FDA 510(k)

FLUOROSET IMMUNOFLUORESCENT ANTIBODY

K-Number: K822785 · 1982-11-29

ApplicantImmulok, Inc.
Decision Date1982-11-29
Product CodeGQL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FLUOROSET 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 1982-11-29 under 510(k) number K822785. The device is classified under product code GQL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUOROSET IMMUNOFLUORESCENT ANTIBODY?

FLUOROSET IMMUNOFLUORESCENT ANTIBODY is a medical device that received FDA 510(k) clearance on 1982-11-29. The listed applicant is Immulok, Inc.. The 510(k) number is K822785.

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

FLUOROSET IMMUNOFLUORESCENT ANTIBODY received FDA 510(k) clearance on 1982-11-29, under 510(k) number K822785.

Who is the listed applicant for FLUOROSET 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 FLUOROSET IMMUNOFLUORESCENT ANTIBODY?

The FDA product code for FLUOROSET IMMUNOFLUORESCENT ANTIBODY is GQL.

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Other records listing Immulok, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GQL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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