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)

LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM

K-Number: K123563 · 2013-08-20

ApplicantMagellan Diagnostics
Decision Date2013-08-20
Product CodeDOF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Magellan Diagnostics. It received FDA 510(k) clearance on 2013-08-20 under 510(k) number K123563. The device is classified under product code DOF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM?

LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-20. The listed applicant is Magellan Diagnostics. The 510(k) number is K123563.

When did LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM receive FDA 510(k) clearance?

LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM received FDA 510(k) clearance on 2013-08-20, under 510(k) number K123563.

Who is the listed applicant for LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM?

The FDA 510(k) record lists Magellan Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM?

The FDA product code for LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM is DOF.

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

Related Devices (Code: DOF)

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.

K052549LEADCARE II BLOOD LEAD TESTING SYSTEMEsa Biosciences, Inc.K971640LEADCARE BLOOD LEAD TESTING SYSTEMEsa, Inc.K936060ATOMSPEC GF BLOOD LEAD WORKSTATIONThermo Jarrell Ash Corp.Div.Thermo Inst.K843839STAT/PB REAGENTTri-Tech, 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.

↑