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)

OCTEIA 25-HYDROXY VITAMIN D

K-Number: K021163 · 2002-05-10

ApplicantImmunodiagnostic Systems , Ltd.
Decision Date2002-05-10
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OCTEIA 25-HYDROXY VITAMIN D is the device name listed in this FDA 510(k) record. The listed applicant is Immunodiagnostic Systems , Ltd.. It received FDA 510(k) clearance on 2002-05-10 under 510(k) number K021163. 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 OCTEIA 25-HYDROXY VITAMIN D?

OCTEIA 25-HYDROXY VITAMIN D is a medical device that received FDA 510(k) clearance on 2002-05-10. The listed applicant is Immunodiagnostic Systems , Ltd.. The 510(k) number is K021163.

When did OCTEIA 25-HYDROXY VITAMIN D receive FDA 510(k) clearance?

OCTEIA 25-HYDROXY VITAMIN D received FDA 510(k) clearance on 2002-05-10, under 510(k) number K021163.

Who is the listed applicant for OCTEIA 25-HYDROXY VITAMIN D?

The FDA 510(k) record lists Immunodiagnostic Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OCTEIA 25-HYDROXY VITAMIN D?

The FDA product code for OCTEIA 25-HYDROXY VITAMIN D is MRG.

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 Immunodiagnostic Systems , Ltd. 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.

K202136IDS CortisolK200475IDS-iSYS Ostase BAPK190121IDS SHBGK161158IDS-iSYS Intact PTHNK161831IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetK161082IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers

View all 19 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.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.

↑