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DNA / Bioinformatics / DNA microarray / Gene expression / Microtechnology / Image scanner / Science / MammaPrint / Microarrays / Biology / Chemistry


510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k101454 B. Purpose for Submission:
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Document Date: 2014-12-05 13:59:58

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File Size: 684,84 KB

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City

Amsterdam / Huntington Beach / /

Company

Agendia BV / Agilent Technologies / Pearson / /

Country

United States / /

Event

FDA Phase / /

Facility

Amsterdam laboratory / US laboratory / /

IndustryTerm

array chip / predicate device / /

MedicalCondition

distant metastasis / tumor / tumors / fresh tumor / II disease / breast tumor / breast cancer / fresh breast cancer / /

Organization

FDA / Amsterdam Lab / /

Position

HB / /

Product

MammaPrint / US22502555 / US45103019 / /

ProvinceOrState

California / /

Technology

array chip / DNA Chip / hybridization / gene expression / /

SocialTag