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)

OMNI C ANALYZER

K-Number: K013373 · 2001-11-02

ApplicantRoche Diagnostics Corp.
Decision Date2001-11-02
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OMNI C ANALYZER 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 2001-11-02 under 510(k) number K013373. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI C ANALYZER?

OMNI C ANALYZER is a medical device that received FDA 510(k) clearance on 2001-11-02. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K013373.

When did OMNI C ANALYZER receive FDA 510(k) clearance?

OMNI C ANALYZER received FDA 510(k) clearance on 2001-11-02, under 510(k) number K013373.

Who is the listed applicant for OMNI C ANALYZER?

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 OMNI C ANALYZER?

The FDA product code for OMNI C ANALYZER is CEM.

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: CEM)

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.

K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutionsRoche DiagnosticsK241037ABL90 FLEX PLUS SystemRadiometer Medicals ApsK220396EasyStat 300Medica CorporationK230890ISE ElectrodesRandox Laboratories, Ltd.K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc.K121012FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A.

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.

↑