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Health / Medical device / Center for Devices and Radiological Health / Premarket approval / Federal Food / Drug / and Cosmetic Act / Title 21 of the Code of Federal Regulations / Adverse event / Investigational Device Exemption / Unique Device Identification / Medicine / Food and Drug Administration / Technology


Public Health Service DEPARTMENT OF HEALTH & HUMAN SERVICES Nick Lewis M.Sc., RAC (US) Regulatory Affairs Manager
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Document Date: 2012-07-11 11:28:55

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File Size: 154,26 KB

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City

Rockville / Drive Pleasanton / /

Company

Regulatory Affairs Manager Roche Molecular Systems Inc. / /

Country

United States / /

Currency

pence / /

Event

FDA Phase / /

Facility

Hacienda Drive Pleasanton / /

IndustryTerm

Internet HomePage / similar device / malfunctioned and such device / diagnostic devices / blood products / automated specimen processing / /

MedicalCondition

serious injury / /

MedicalTreatment

organ transplant / /

Organization

Health PMA Document Mail Center / Microbiology Devices Office / Food and Drug Administration / Center for Devices and Radiological Health / U.S. Food and Drug Administration Center for Devices / DEPARTMENT OF HEALTH / /

Person

Sally A. Hojvat / Nick Lewis / /

/

Position

Director / Division / /

Product

W066-G609 / COBAS® AmpliPrep / PMA supplement / /

ProvinceOrState

Maryland / California / /

Technology

approved protocol / /

URL

www.fda.pov/Safetv/Recalls/IndustrvGuidance/default.htm / http /

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