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)

ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET

K-Number: K103716 · 2011-05-12

ApplicantRoche Diagnostics
Decision Date2011-05-12
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2011-05-12 under 510(k) number K103716. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET?

ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET is a medical device that received FDA 510(k) clearance on 2011-05-12. The listed applicant is Roche Diagnostics. The 510(k) number is K103716.

When did ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET receive FDA 510(k) clearance?

ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET received FDA 510(k) clearance on 2011-05-12, under 510(k) number K103716.

Who is the listed applicant for ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET?

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 ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET?

The FDA product code for ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET is CGN.

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: CGN)

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.

K233060Elecsys Folate IIIRoche DiagnosticsK223590Access Folate AssayBeckman Coulter, Inc.K192586LIAISON® FolateDiaSorin, Inc.K172201Atellica IM Folate AssaySiemens Healthcare Diagnostics, Inc.K161646Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control SetDiazyme LaboratoriesK092740ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74Abbott Laboratories

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.

↑