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FDA 510(k)

DU PONT VCA-IGM ANTIBODY ELISA KIT

K-Number: K875204 · 1988-07-08

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1988-07-08
Product CodeLJN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DU PONT VCA-IGM 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 1988-07-08 under 510(k) number K875204. The device is classified under product code LJN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DU PONT VCA-IGM ANTIBODY ELISA KIT?

DU PONT VCA-IGM ANTIBODY ELISA KIT is a medical device that received FDA 510(k) clearance on 1988-07-08. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K875204.

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

DU PONT VCA-IGM ANTIBODY ELISA KIT received FDA 510(k) clearance on 1988-07-08, under 510(k) number K875204.

Who is the listed applicant for DU PONT VCA-IGM 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 VCA-IGM ANTIBODY ELISA KIT?

The FDA product code for DU PONT VCA-IGM ANTIBODY ELISA KIT is LJN.

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

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Related Devices (Code: LJN)

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.

K123021BIOPLEX 2200 EBV IGM KITBio-Rad LaboratoriesK073381PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600MFocus Diagnostics, Inc.K042092ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEMZeus Scientific, Inc.K033780MODIFICATION TO SERAQUEST VCA IGMQuest Intl., Inc.K990977SERAQUEST EB VAC IGMQuest Intl., Inc.K991459COPALIS EBV-M ANTIBODY ASSAYDiaSorin, 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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