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Immunologic tests / Glands / Immunoassay / Thyroid function tests / Thyroid / Thyroxine / Assay / Chemistry / Anatomy / Biology


5.0 SUBMITTED BY: DATE PREPARED: 51 0(k) SUMMARY
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Document Date: 2013-05-06 11:19:24

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City

Stillwater / /

Company

DiaSorin Inc. / CVs / In Vitro Diagnostics / K121951 Trade / R. Sauer Regulatory Affairs Specialist DiaSorin Inc. / /

Event

FDA Phase / /

Facility

New Harnpshire Avenue Document Control Center / Same Reagent Format Lyophilized Same Same store / /

/

IndustryTerm

intermediate stock solutions / Internet address lhttp /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / refrigerator@ Storage 2-80C Sample AtmtdSm Handling/Processing AtmtdSm Unit of Measure ng/dL / New Harnpshire Avenue Document Control Center / Radiological Health Center for Devices and Radiological Health Enclosure / FDA / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / Chemistry and Toxicology Devices Office / /

Person

Assignment / Courtney H. Lias / KELLY R SAUER / Carol C.Benson / Asa yeChemiluminescent / /

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Position

Director / Division / Calibrator / REGULATORY AFFAIRS SPECIALIST / /

Product

Phenylbutazone / Furosemide / Federal Food / EP5-A2 / LIAISON® FT4 / LIAISON / /

ProvinceOrState

Maryland / Minnesota / /

Technology

radiation / testing protocol / /

URL

http /

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