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FDA 510(k)

LYME IGM MICROASSAY

K-Number: K911330 · 1991-06-10

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

Device Summary

LYME IGM 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 K911330. 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 IGM MICROASSAY?

LYME IGM 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 K911330.

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

LYME IGM MICROASSAY received FDA 510(k) clearance on 1991-06-10, under 510(k) number K911330.

Who is the listed applicant for LYME IGM 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 IGM MICROASSAY?

The FDA product code for LYME IGM MICROASSAY is LSR.

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Other records listing Diamedix Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K093101MAGO 4SK021394DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEMK013956DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREENK013628DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEMK012450DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEMK012449DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM

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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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