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 Vitamin D total III

K-Number: K210901 · 2021-09-01

ApplicantRoche Diagnostics
Decision Date2021-09-01
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Elecsys Vitamin D total III is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2021-09-01 under 510(k) number K210901. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys Vitamin D total III?

Elecsys Vitamin D total III is a medical device that received FDA 510(k) clearance on 2021-09-01. The listed applicant is Roche Diagnostics. The 510(k) number is K210901.

When did Elecsys Vitamin D total III receive FDA 510(k) clearance?

Elecsys Vitamin D total III received FDA 510(k) clearance on 2021-09-01, under 510(k) number K210901.

Who is the listed applicant for Elecsys Vitamin D total III?

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 Vitamin D total III?

The FDA product code for Elecsys Vitamin D total III is MRG.

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.

K252323cobas pulse blood glucose monitoring systemPMA P990056Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancerPMA P000027PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERSK252431Elecsys CalcitoninK252280Elecsys Anti-SARS-CoV-2 SK260049Elecsys Anti-HBc IgM

View all 84 devices →

Related Devices (Code: MRG)

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.

K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,K223503Access 25(OH) Vitamin D TotalBeckman Coulter, Inc.K200509ADVIA Centaur Vitamin D Total (VitD)Siemens Healthcare Diagnostics, Inc.K191499MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd.K180577BioPlex 2200 25-OH Vitamin D KitBio-Rad 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.

↑