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FDA 510(k)

RHEUMANOSTICON R

K-Number: K771410 · 1977-09-02

ApplicantOrganon, Inc.
Decision Date1977-09-02
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHEUMANOSTICON R is the device name listed in this FDA 510(k) record. The listed applicant is Organon, Inc.. It received FDA 510(k) clearance on 1977-09-02 under 510(k) number K771410. 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 RHEUMANOSTICON R?

RHEUMANOSTICON R is a medical device that received FDA 510(k) clearance on 1977-09-02. The listed applicant is Organon, Inc.. The 510(k) number is K771410.

When did RHEUMANOSTICON R receive FDA 510(k) clearance?

RHEUMANOSTICON R received FDA 510(k) clearance on 1977-09-02, under 510(k) number K771410.

Who is the listed applicant for RHEUMANOSTICON R?

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

What is the FDA product code for RHEUMANOSTICON R?

The FDA product code for RHEUMANOSTICON R is DHR.

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Other records listing Organon, 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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