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Blood tests / Biology / Total iron-binding capacity / Serum iron / Iron tests / Iron deficiency anemia / Clinical chemistry / Medical device / Iron deficiency / Iron metabolism / Medicine / Chemistry


k113438, page[removed]k) SUMMARY 5 10(k) Owner: JN
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Document Date: 2012-07-06 14:43:27

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File Size: 316,56 KB

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City

West Caldwell / /

Company

MD 20993 Alfa Wassermann Diagnostic Technologies / JN 121 Alfa Wassermann Diagnostic Technologies LLC / ACE / /

Event

FDA Phase / /

/

IndustryTerm

announcements concerning your device / predicate device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / /

MedicalCondition

iron deficiency / disease / iron deficiency anemia / chronic renal disease / diseases / acute pancreatitis / anemia / hemochromatosis / /

Organization

Division Sign-Off Office / Division of Postmarket Surveillance / Food and Drug Administration / United Nations / office of Surveillance / In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure Indications for Use / office of Surveillance and Biometric / Physician Office Laboratory / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Division of Chemistry / Chemistry and Toxicology Devices Office / /

Person

Hyman Katz / /

/

Position

Vice President / Quality and Regulatory Affairs / physician / /

Product

Axcel Clinical Chemistry System / sodium bicarbonate / Federal Food / /

ProvinceOrState

New Jersey / /

Technology

random access / /

URL

http /

SocialTag