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FDA 510(k)

IGM RHEUMATOID FACTOR

K-Number: K942272 · 1994-09-26

ApplicantImmco Diagnostics, Inc.
Decision Date1994-09-26
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IGM RHEUMATOID FACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 1994-09-26 under 510(k) number K942272. 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 IGM RHEUMATOID FACTOR?

IGM RHEUMATOID FACTOR is a medical device that received FDA 510(k) clearance on 1994-09-26. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K942272.

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

IGM RHEUMATOID FACTOR received FDA 510(k) clearance on 1994-09-26, under 510(k) number K942272.

Who is the listed applicant for IGM RHEUMATOID FACTOR?

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

What is the FDA product code for IGM RHEUMATOID FACTOR?

The FDA product code for IGM RHEUMATOID FACTOR is DHR.

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Other records listing Immco Diagnostics, Inc. as applicant

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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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