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)

PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC

K-Number: K050026 · 2005-01-31

ApplicantRoche Diagnostics
Decision Date2005-01-31
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2005-01-31 under 510(k) number K050026. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC?

PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC is a medical device that received FDA 510(k) clearance on 2005-01-31. The listed applicant is Roche Diagnostics. The 510(k) number is K050026.

When did PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC receive FDA 510(k) clearance?

PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC received FDA 510(k) clearance on 2005-01-31, under 510(k) number K050026.

Who is the listed applicant for PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC?

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

What is the FDA product code for PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC?

The FDA product code for PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC is JIX.

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 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.

K261686Elecsys Phospho-Tau (217P) PlasmaK252323cobas pulse blood glucose monitoring systemK252280Elecsys Anti-SARS-CoV-2 SK260048Elecsys Anti-HAV IgMK260049Elecsys Anti-HBc IgMK260046Elecsys Anti-HBc II

View all 164 devices →

Related Devices (Code: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, 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.

↑