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FDA 510(k)

LEADCARE II BLOOD LEAD TESTING SYSTEM

K-Number: K052549 · 2005-10-06

ApplicantEsa Biosciences, Inc.
Decision Date2005-10-06
Product CodeDOF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LEADCARE II BLOOD LEAD TESTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Esa Biosciences, Inc.. It received FDA 510(k) clearance on 2005-10-06 under 510(k) number K052549. 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 II BLOOD LEAD TESTING SYSTEM?

LEADCARE II BLOOD LEAD TESTING SYSTEM is a medical device that received FDA 510(k) clearance on 2005-10-06. The listed applicant is Esa Biosciences, Inc.. The 510(k) number is K052549.

When did LEADCARE II BLOOD LEAD TESTING SYSTEM receive FDA 510(k) clearance?

LEADCARE II BLOOD LEAD TESTING SYSTEM received FDA 510(k) clearance on 2005-10-06, under 510(k) number K052549.

Who is the listed applicant for LEADCARE II BLOOD LEAD TESTING SYSTEM?

The FDA 510(k) record lists Esa Biosciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEADCARE II BLOOD LEAD TESTING SYSTEM?

The FDA product code for LEADCARE II 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

Other records listing Esa Biosciences, Inc. 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.

K072536ESA BIOSCIENCES INC. VITAMIN D HPLC TEST

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.

K123563LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEMMagellan DiagnosticsK971640LEADCARE 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.

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