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FDA 510(k)

EBNA-1 IGM ELISA TEST SYSTEM

K-Number: K982348 · 1998-11-25

ApplicantColumbia Bioscience, Inc.
Decision Date1998-11-25
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBNA-1 IGM ELISA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Columbia Bioscience, Inc.. It received FDA 510(k) clearance on 1998-11-25 under 510(k) number K982348. The device is classified under product code LSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBNA-1 IGM ELISA TEST SYSTEM?

EBNA-1 IGM ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1998-11-25. The listed applicant is Columbia Bioscience, Inc.. The 510(k) number is K982348.

When did EBNA-1 IGM ELISA TEST SYSTEM receive FDA 510(k) clearance?

EBNA-1 IGM ELISA TEST SYSTEM received FDA 510(k) clearance on 1998-11-25, under 510(k) number K982348.

Who is the listed applicant for EBNA-1 IGM ELISA TEST SYSTEM?

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

What is the FDA product code for EBNA-1 IGM ELISA TEST SYSTEM?

The FDA product code for EBNA-1 IGM ELISA TEST SYSTEM is LSE.

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Other records listing Columbia Bioscience, 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: LSE)

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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