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FDA 510(k)

25OH VITAMIN D TOTAL ELISA TEST

K-Number: K123364 · 2013-07-15

ApplicantDiasource Immunoassays, S.A.
Decision Date2013-07-15
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

25OH VITAMIN D TOTAL ELISA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Diasource Immunoassays, S.A.. It received FDA 510(k) clearance on 2013-07-15 under 510(k) number K123364. 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 25OH VITAMIN D TOTAL ELISA TEST?

25OH VITAMIN D TOTAL ELISA TEST is a medical device that received FDA 510(k) clearance on 2013-07-15. The listed applicant is Diasource Immunoassays, S.A.. The 510(k) number is K123364.

When did 25OH VITAMIN D TOTAL ELISA TEST receive FDA 510(k) clearance?

25OH VITAMIN D TOTAL ELISA TEST received FDA 510(k) clearance on 2013-07-15, under 510(k) number K123364.

Who is the listed applicant for 25OH VITAMIN D TOTAL ELISA TEST?

The FDA 510(k) record lists Diasource Immunoassays, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 25OH VITAMIN D TOTAL ELISA TEST?

The FDA product code for 25OH VITAMIN D TOTAL ELISA TEST is MRG.

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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.K210901Elecsys Vitamin D total IIIRoche DiagnosticsK200509ADVIA Centaur Vitamin D Total (VitD)Siemens Healthcare Diagnostics, Inc.K191499MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd.

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.

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