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Biology / Electrolyte disturbances / Nephrology / Blood tests / Hypomagnesemia / Intensive care medicine / Hypermagnesemia / Low-density lipoprotein / Medicine / Magnesium / Chemistry


DEC 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE A.510(k) Number: K1 11915
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Document Date: 2012-01-30 00:31:01

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File Size: 239,43 KB

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City

Philadelphia / Concentration Total / Charlottetown / Run / /

Company

Beckman Coulter / W.B. Saunders Company / Clinical Laboratory / Hitachi / /

Event

FDA Phase / /

Facility

Laboratory Tests / Magnesium complex / /

IndustryTerm

manufacturing / /

Organization

Food and Drug Administration / African Union / /

Person

H. Lias / Cosmetic Act (Act) / Penny White / /

/

Position

Major / Editor / /

Product

EP1 / C28-A2 / EP6-A / EP7-A2 / EP9-A2 / /

ProgrammingLanguage

C / /

ProvinceOrState

Maryland / Prince Edward Island / /

URL

www.fda.gov/MedicalDevices/Resoui-cesforYou/Lnidustry/defaulthtm / http /

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