Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II

K-Number: K000534 · 2000-04-05

ApplicantRoche Diagnostics Corp.
Decision Date2000-04-05
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2000-04-05 under 510(k) number K000534. 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 COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II?

COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II is a medical device that received FDA 510(k) clearance on 2000-04-05. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K000534.

When did COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II receive FDA 510(k) clearance?

COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II received FDA 510(k) clearance on 2000-04-05, under 510(k) number K000534.

Who is the listed applicant for COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II?

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

What is the FDA product code for COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II?

The FDA product code for COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II 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 Roche Diagnostics Corp. 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.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

View all 263 devices →

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.

↑