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FDA 510(k)

CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM

K-Number: K953261 · 1995-08-15

ApplicantShared Systems, Inc.
Decision Date1995-08-15
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Shared Systems, Inc.. It received FDA 510(k) clearance on 1995-08-15 under 510(k) number K953261. 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 CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM?

CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1995-08-15. The listed applicant is Shared Systems, Inc.. The 510(k) number is K953261.

When did CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM receive FDA 510(k) clearance?

CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM received FDA 510(k) clearance on 1995-08-15, under 510(k) number K953261.

Who is the listed applicant for CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM?

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

What is the FDA product code for CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM?

The FDA product code for CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Shared Systems, 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.

K973457CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800K955042CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEMK950073MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEMK920212MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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