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FDA 510(k)

DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM

K-Number: K021394 · 2002-07-09

ApplicantDiamedix Corp.
Decision Date2002-07-09
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diamedix Corp.. It received FDA 510(k) clearance on 2002-07-09 under 510(k) number K021394. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM?

DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2002-07-09. The listed applicant is Diamedix Corp.. The 510(k) number is K021394.

When did DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM receive FDA 510(k) clearance?

DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM received FDA 510(k) clearance on 2002-07-09, under 510(k) number K021394.

Who is the listed applicant for DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM?

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 DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM?

The FDA product code for DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM is DHR.

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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 4SK013956DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREENK013628DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEMK012449DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEMK012450DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEMK012795DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM

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Related Devices (Code: DHR)

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.

K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)Kamiya Biomedical CompanyK190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsInova Diagnostics, Inc.K182747EliA RF IgM ImmunoassayPhadia ABK162263Optilite Rheumatoid Factor KitThe Binding Site Group , Ltd.K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group , Ltd.K102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMPhadia US, 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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