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FDA 510(k)

IGM RHEUMATOID FACTOR TEST KIT

K-Number: K851099 · 1985-04-25

ApplicantBreit Laboratories, Inc.
Decision Date1985-04-25
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IGM RHEUMATOID FACTOR TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Breit Laboratories, Inc.. It received FDA 510(k) clearance on 1985-04-25 under 510(k) number K851099. 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 TEST KIT?

IGM RHEUMATOID FACTOR TEST KIT is a medical device that received FDA 510(k) clearance on 1985-04-25. The listed applicant is Breit Laboratories, Inc.. The 510(k) number is K851099.

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

IGM RHEUMATOID FACTOR TEST KIT received FDA 510(k) clearance on 1985-04-25, under 510(k) number K851099.

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

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

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

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

Related Clinical Trials

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.

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Other records listing Breit Laboratories, Inc. 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.

K840527COLOTRAK OCCULT BLOOD TESTK842137OCCULT BLOOD TESTK832031ANTI-N DNA ANTIBODY TEST KITK831927ANTINUCLEAR ANTIBODY TEST KIT

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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