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FDA 510(k)

RHEUMACOL RHEUMATOID FACTOR TEST

K-Number: K972456 · 1997-11-25

ApplicantImmunostics Inc.,
Decision Date1997-11-25
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHEUMACOL RHEUMATOID FACTOR TEST is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Inc.,. It received FDA 510(k) clearance on 1997-11-25 under 510(k) number K972456. 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 RHEUMACOL RHEUMATOID FACTOR TEST?

RHEUMACOL RHEUMATOID FACTOR TEST is a medical device that received FDA 510(k) clearance on 1997-11-25. The listed applicant is Immunostics Inc.,. The 510(k) number is K972456.

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

RHEUMACOL RHEUMATOID FACTOR TEST received FDA 510(k) clearance on 1997-11-25, under 510(k) number K972456.

Who is the listed applicant for RHEUMACOL RHEUMATOID FACTOR TEST?

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

What is the FDA product code for RHEUMACOL RHEUMATOID FACTOR TEST?

The FDA product code for RHEUMACOL RHEUMATOID FACTOR TEST is DHR.

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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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