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FDA 510(k)

FIAX RHEUMATOID FACTOR TEST KIT

K-Number: K812968 · 1981-11-06

ApplicantIntl. Diagnostic Technology
Decision Date1981-11-06
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FIAX RHEUMATOID FACTOR TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Diagnostic Technology. It received FDA 510(k) clearance on 1981-11-06 under 510(k) number K812968. 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 FIAX RHEUMATOID FACTOR TEST KIT?

FIAX RHEUMATOID FACTOR TEST KIT is a medical device that received FDA 510(k) clearance on 1981-11-06. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K812968.

When did FIAX RHEUMATOID FACTOR TEST KIT receive FDA 510(k) clearance?

FIAX RHEUMATOID FACTOR TEST KIT received FDA 510(k) clearance on 1981-11-06, under 510(k) number K812968.

Who is the listed applicant for FIAX RHEUMATOID FACTOR TEST KIT?

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

What is the FDA product code for FIAX RHEUMATOID FACTOR TEST KIT?

The FDA product code for FIAX RHEUMATOID FACTOR TEST KIT is DHR.

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Other records listing Intl. Diagnostic Technology 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.

K850591FIAX TOXO-M ANTIBODIES TEST KITK843570FIAX HAPTOGLOBIN TEST KITK843621FIAX 420 DILUTORK843356FIAX 100 FLUOROMETERK842749FIAX TOTAL IGE TEST KITK842071FIAX TRANSFERRIN TEST KIT

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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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