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FDA 510(k)

MEASLES IGG MICROASSAY

K-Number: K903961 · 1990-12-28

ApplicantDiamedix Corp.
Decision Date1990-12-28
Product CodeLJB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MEASLES IGG 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 1990-12-28 under 510(k) number K903961. The device is classified under product code LJB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEASLES IGG MICROASSAY?

MEASLES IGG MICROASSAY is a medical device that received FDA 510(k) clearance on 1990-12-28. The listed applicant is Diamedix Corp.. The 510(k) number is K903961.

When did MEASLES IGG MICROASSAY receive FDA 510(k) clearance?

MEASLES IGG MICROASSAY received FDA 510(k) clearance on 1990-12-28, under 510(k) number K903961.

Who is the listed applicant for MEASLES IGG 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 MEASLES IGG MICROASSAY?

The FDA product code for MEASLES IGG MICROASSAY is LJB.

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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: LJB)

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.

K974552DIAMEDIX IS-MEASLES IGG TEST SYSTEMDiamedix Corp.K971620QUANTA LITE RUBEOLA (MEASLES) IGGInova Diagnostics, Inc.K922330BARTELS RUBEOLA IGG EIABaxter Diagnostics, Inc.K922335BARTELS RUBEOLA IGM EIABaxter Diagnostics, Inc.K910290VIRATEST-DIA(TM) MEASLES (RUBEOLA)Virus Reference Laboratory, Inc.K904083RUBEOLA IGM ELISA TESTGull Laboratories, Inc.

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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