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Amino acids / Medicine / Nephrology / Renal physiology / Creatinine / Metabolism / Blood urea nitrogen / Sarcosine / Creatininase / Biology / Chemistry / Guanidines


Inspire the Next 510(k) SUMMARY T]his summary of -510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CE-R[removed]The assigned 510(k) number is K132462
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Document Date: 2013-11-14 08:33:34


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City

View / Indianapolis / Mountain View / /

Company

Roche Diagnostics Inc. / HitachiChemical Diagnostics Inc. / CVs / 8 Q Hitachi Chemical Dlagnostics Inc. / Roehe Diagnostics Inc. / Hitachi Chemical Diagnostics Inc. / S SHitachi Chemical Diagnostics / /

/

IndustryTerm

test systems / treatment of renal diseases / marketed predicate devices / /

MedicalCondition

renal diseases / renal and metabolic diseases / /

MedicalTreatment

renal dialysis / /

Organization

United Nations / Clyde Court / Inc. 63D Clyde Court / /

Person

Clyde Court / Sallie Intended / Erika Ammiirati / /

/

Position

physician / Consultant / /

Product

Glycine / Intralipid / /

ProgrammingLanguage

K / /

ProvinceOrState

California / /

Technology

condensation / lua / dialysis / /

URL

www.hCdiadnostics.com / www.hcdiagnostics.com / www.hcdlagndSticSc6h / www.hciagnosticstcbm / /

SocialTag