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FDA 510(k)

IS BORRELIA BURGDORFERI IGM TEST SYSTEM

K-Number: K983606 · 1998-12-16

ApplicantColumbia Bioscience, Inc.
Decision Date1998-12-16
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IS BORRELIA BURGDORFERI IGM 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 1998-12-16 under 510(k) number K983606. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IS BORRELIA BURGDORFERI IGM TEST SYSTEM?

IS BORRELIA BURGDORFERI IGM TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1998-12-16. The listed applicant is Columbia Bioscience, Inc.. The 510(k) number is K983606.

When did IS BORRELIA BURGDORFERI IGM TEST SYSTEM receive FDA 510(k) clearance?

IS BORRELIA BURGDORFERI IGM TEST SYSTEM received FDA 510(k) clearance on 1998-12-16, under 510(k) number K983606.

Who is the listed applicant for IS BORRELIA BURGDORFERI IGM 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 BORRELIA BURGDORFERI IGM TEST SYSTEM?

The FDA product code for IS BORRELIA BURGDORFERI IGM TEST SYSTEM is LSR.

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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.

K991274MUMPS IGG ELISA TEST SYSTEMK990462IS H. PYLORI IGG ELISA TEST SYSTEMK984228IS ANTI-TPO IGG ELISA TEST SYSTEMK983605IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEMK983553ANTI-TG IGG ELISA TEST SYSTEMK982350EA-D IGM ELISA TEST SYSTEM

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Related Devices (Code: LSR)

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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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