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FDA 510(k)

BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY

K-Number: K885290 · 1989-04-10

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

Device Summary

BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY 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 K885290. 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 POLYVALENT IGG/IGM ANTIBODY?

BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY 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 K885290.

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

BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY received FDA 510(k) clearance on 1989-04-10, under 510(k) number K885290.

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

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 POLYVALENT IGG/IGM ANTIBODY?

The FDA product code for BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY 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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