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FDA 510(k)

IS H. PYLORI IGG ELISA TEST SYSTEM

K-Number: K990462 · 1999-09-03

ApplicantColumbia Bioscience, Inc.
Decision Date1999-09-03
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IS H. PYLORI IGG 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 1999-09-03 under 510(k) number K990462. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IS H. PYLORI IGG ELISA TEST SYSTEM?

IS H. PYLORI IGG ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1999-09-03. The listed applicant is Columbia Bioscience, Inc.. The 510(k) number is K990462.

When did IS H. PYLORI IGG ELISA TEST SYSTEM receive FDA 510(k) clearance?

IS H. PYLORI IGG ELISA TEST SYSTEM received FDA 510(k) clearance on 1999-09-03, under 510(k) number K990462.

Who is the listed applicant for IS H. PYLORI IGG 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 IS H. PYLORI IGG ELISA TEST SYSTEM?

The FDA product code for IS H. PYLORI IGG ELISA TEST SYSTEM is LYR.

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Other records listing Columbia Bioscience, Inc. as applicant

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Related Devices (Code: LYR)

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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