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FDA 510(k)

LYME DISEASE MICROASSAY

K-Number: K910899 · 1991-06-10

ApplicantDiamedix Corp.
Decision Date1991-06-10
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LYME DISEASE MICROASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Diamedix Corp.. It received FDA 510(k) clearance on 1991-06-10 under 510(k) number K910899. 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 LYME DISEASE MICROASSAY?

LYME DISEASE MICROASSAY is a medical device that received FDA 510(k) clearance on 1991-06-10. The listed applicant is Diamedix Corp.. The 510(k) number is K910899.

When did LYME DISEASE MICROASSAY receive FDA 510(k) clearance?

LYME DISEASE MICROASSAY received FDA 510(k) clearance on 1991-06-10, under 510(k) number K910899.

Who is the listed applicant for LYME DISEASE MICROASSAY?

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

What is the FDA product code for LYME DISEASE MICROASSAY?

The FDA product code for LYME DISEASE MICROASSAY is LSR.

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Other records listing Diamedix Corp. as applicant

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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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