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FDA 510(k)

LEADCARE BLOOD LEAD TESTING SYSTEM

K-Number: K971640 · 1997-09-09

ApplicantEsa, Inc.
Decision Date1997-09-09
Product CodeDOF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LEADCARE BLOOD LEAD TESTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Esa, Inc.. It received FDA 510(k) clearance on 1997-09-09 under 510(k) number K971640. 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 BLOOD LEAD TESTING SYSTEM?

LEADCARE BLOOD LEAD TESTING SYSTEM is a medical device that received FDA 510(k) clearance on 1997-09-09. The listed applicant is Esa, Inc.. The 510(k) number is K971640.

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

LEADCARE BLOOD LEAD TESTING SYSTEM received FDA 510(k) clearance on 1997-09-09, under 510(k) number K971640.

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

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

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

The FDA product code for LEADCARE BLOOD LEAD TESTING SYSTEM is DOF.

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Other records listing Esa, 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.

K032199ESA PLASMA FREE METANEPHRINE ANALYSIS KITK963938MODEL 5500 CEASK934977MODEL 5500 CEASK931148MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEMK903231COULOCHEM IIK864729NEUROCHEMICAL ANALYZER

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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 DiagnosticsK052549LEADCARE II BLOOD LEAD TESTING SYSTEMEsa Biosciences, 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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