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FDA 510(k)

BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM

K-Number: K885294 · 1989-04-10

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1989-04-10
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1989-04-10 under 510(k) number K885294. 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 BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM?

BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1989-04-10. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K885294.

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

BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM received FDA 510(k) clearance on 1989-04-10, under 510(k) number K885294.

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

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

What is the FDA product code for BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM?

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

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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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