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FDA 510(k)

BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST

K-Number: K911145 · 1991-05-10

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1991-05-10
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST 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 1991-05-10 under 510(k) number K911145. 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 POLYVAL IGG/IGM ANTIBODY TEST?

BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 1991-05-10. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K911145.

When did BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST receive FDA 510(k) clearance?

BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST received FDA 510(k) clearance on 1991-05-10, under 510(k) number K911145.

Who is the listed applicant for BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST?

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 POLYVAL IGG/IGM ANTIBODY TEST?

The FDA product code for BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST is 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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