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FDA 510(k)

DU PONT EBNA-IGG ANTIBODY ELISA KIT

K-Number: K875203 · 1988-08-30

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1988-08-30
Product CodeLLM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DU PONT EBNA-IGG ANTIBODY ELISA KIT is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1988-08-30 under 510(k) number K875203. 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 DU PONT EBNA-IGG ANTIBODY ELISA KIT?

DU PONT EBNA-IGG ANTIBODY ELISA KIT is a medical device that received FDA 510(k) clearance on 1988-08-30. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K875203.

When did DU PONT EBNA-IGG ANTIBODY ELISA KIT receive FDA 510(k) clearance?

DU PONT EBNA-IGG ANTIBODY ELISA KIT received FDA 510(k) clearance on 1988-08-30, under 510(k) number K875203.

Who is the listed applicant for DU PONT EBNA-IGG ANTIBODY ELISA KIT?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DU PONT EBNA-IGG ANTIBODY ELISA KIT?

The FDA product code for DU PONT EBNA-IGG ANTIBODY ELISA KIT is LLM.

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Other records listing E.I. Dupont DE Nemours & Co., 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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