Back to Results
First PageMeta Content
Medical device / Immunoassay / Premarket approval / CA19-9 / Federal Food / Drug / and Cosmetic Act / Center for Devices and Radiological Health / Quality management system / Medicine / Food and Drug Administration / Health


510(k) Summary of Safety and Effectiveness for the LOCI CA[removed]CA19-9) Flex® Reagent Cartridge APR Dimension Vista® LOCI 7 Calibrator
Add to Reading List

Document Date: 2011-05-30 00:42:58

Open Document

File Size: 191,37 KB

Share Result on Facebook

City

Newark / Centaur / /

Company

Siemens Healthcare Diagnostics Inc. / MD 20993 Siemens Healthcare Diagnostics / /

Currency

pence / /

/

IndustryTerm

manufacturing / predicate device / /

MedicalCondition

Pancreatic Cancer / /

OperatingSystem

Microsoft Vista / /

Organization

Food and Drug Administration / DEPARTMENT OF HEALTH / /

Person

Maria M. Chan / Pamela A. Jurga / Pamnela A. Jurga / Cosmetic Act (Act) / /

/

Position

Calibrator / Major / Director / Affairs Specialist Office / /

ProvinceOrState

Delaware / /

URL

http /

SocialTag