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FDA 510(k)

MARDX LYME DISEASE IFA (IGM) TEST SYSTEM

K-Number: K894609 · 1989-09-19

ApplicantMardx, Inc.
Decision Date1989-09-19
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MARDX LYME DISEASE IFA (IGM) TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mardx, Inc.. It received FDA 510(k) clearance on 1989-09-19 under 510(k) number K894609. 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 MARDX LYME DISEASE IFA (IGM) TEST SYSTEM?

MARDX LYME DISEASE IFA (IGM) TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1989-09-19. The listed applicant is Mardx, Inc.. The 510(k) number is K894609.

When did MARDX LYME DISEASE IFA (IGM) TEST SYSTEM receive FDA 510(k) clearance?

MARDX LYME DISEASE IFA (IGM) TEST SYSTEM received FDA 510(k) clearance on 1989-09-19, under 510(k) number K894609.

Who is the listed applicant for MARDX LYME DISEASE IFA (IGM) TEST SYSTEM?

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

What is the FDA product code for MARDX LYME DISEASE IFA (IGM) TEST SYSTEM?

The FDA product code for MARDX LYME DISEASE IFA (IGM) TEST SYSTEM is LSR.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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