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FDA 510(k)

EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)

K-Number: K895708 · 1989-12-11

ApplicantImmuno Concepts, Inc.
Decision Date1989-12-11
Product CodeLLM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Concepts, Inc.. It received FDA 510(k) clearance on 1989-12-11 under 510(k) number K895708. The device is classified under product code LLM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)?

EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) is a medical device that received FDA 510(k) clearance on 1989-12-11. The listed applicant is Immuno Concepts, Inc.. The 510(k) number is K895708.

When did EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) receive FDA 510(k) clearance?

EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) received FDA 510(k) clearance on 1989-12-11, under 510(k) number K895708.

Who is the listed applicant for EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)?

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

What is the FDA product code for EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)?

The FDA product code for EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) is LLM.

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Other records listing Immuno Concepts, Inc. as applicant

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Related Devices (Code: LLM)

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.

K233605ADVIA Centaur EBV-EBNA IgGBiokit, S.A.K040120DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYSDiaSorin, Inc.K984133THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K973941IMMUNOWELL EBNA IGG TESTGenbioK980598EBNA-1 IGM ELISA TEST SYSTEMClark Laboratories, Inc.K951549EBNA IGG EIA TEST SYSTEMImmunoprobe, Inc.

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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