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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lipase hydrolysis/glycerol kinase enzyme, triglycerides
510(k) Number K905601
Device Name ECLIPSE ICA TRIGLYCERIDES
Applicant
BIOTOPE, INC.
12277 134TH CT., N.E.
REDMOND,  WA  98052
Applicant Contact LYNN SHANTA
Correspondent
BIOTOPE, INC.
12277 134TH CT., N.E.
REDMOND,  WA  98052
Correspondent Contact LYNN SHANTA
Regulation Number862.1705
Classification Product Code
CDT  
Date Received12/13/1990
Decision Date 01/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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