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)

ELECSYS CEA CALCHECK 5

K-Number: K101856 · 2010-10-05

ApplicantRoche Diagnostics
Decision Date2010-10-05
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS CEA CALCHECK 5 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2010-10-05 under 510(k) number K101856. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS CEA CALCHECK 5?

ELECSYS CEA CALCHECK 5 is a medical device that received FDA 510(k) clearance on 2010-10-05. The listed applicant is Roche Diagnostics. The 510(k) number is K101856.

When did ELECSYS CEA CALCHECK 5 receive FDA 510(k) clearance?

ELECSYS CEA CALCHECK 5 received FDA 510(k) clearance on 2010-10-05, under 510(k) number K101856.

Who is the listed applicant for ELECSYS CEA CALCHECK 5?

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 ELECSYS CEA CALCHECK 5?

The FDA product code for ELECSYS CEA CALCHECK 5 is JJX.

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: JJX)

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.

K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162173Elecsys CYFRA 21-1 CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, 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.

↑