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Accu-chek / Biology / Blood sugar / Glucose test / Test strip / Physiology / Glucose meter / Blood tests / Diabetes / Medicine


Page 1 of[removed]k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE A. 510(k) Number: k043474
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Document Date: 2012-05-11 15:11:17

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File Size: 403,46 KB

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City

Mean / /

Company

Roche Diagnostics Corp. / Blood Glucose Systems / Hitachi / /

Event

FDA Phase / /

Holiday

Between Day / /

IndustryTerm

physician site / fingertip site / dehydrogenase technology / strip technology / control solutions / lancet device / control solution / predicate device / /

MedicalCondition

diabetes / /

Person

Galactose Lipidemia / Aviva Automatically / /

Position

physician / mediator / /

Product

Xylose / K022171 / /

ProgrammingLanguage

DC / L / /

Technology

Test sample volume Test time Expiration Test strip technology / Glucose dehydrogenase technology / /

SocialTag