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FDA 510(k)

EBNA IGG EIA TEST SYSTEM

K-Number: K951549 · 1996-04-29

ApplicantImmunoprobe, Inc.
Decision Date1996-04-29
Product CodeLLM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBNA IGG EIA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Immunoprobe, Inc.. It received FDA 510(k) clearance on 1996-04-29 under 510(k) number K951549. 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 IGG EIA TEST SYSTEM?

EBNA IGG EIA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1996-04-29. The listed applicant is Immunoprobe, Inc.. The 510(k) number is K951549.

When did EBNA IGG EIA TEST SYSTEM receive FDA 510(k) clearance?

EBNA IGG EIA TEST SYSTEM received FDA 510(k) clearance on 1996-04-29, under 510(k) number K951549.

Who is the listed applicant for EBNA IGG EIA TEST SYSTEM?

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

What is the FDA product code for EBNA IGG EIA TEST SYSTEM?

The FDA product code for EBNA IGG EIA TEST SYSTEM is LLM.

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Other records listing Immunoprobe, 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.

K972406ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEMK971393MYCOPLASMA IGG ELISA TEST SYSTEMK961764PR-3 ELISA TEST SYSTEMK961765MPO ELISA TEST SYSTEMK952521CARDIOLIPIN IGM EIA TEST SYSTEMK952522CARDIOLIPIN IGA EIA TEST SYSTEM

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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.K951822EBNA ENZYME IMMUNOASSAY KITGranbio, 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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