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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name urease and glutamic dehydrogenase, urea nitrogen
510(k) Number K905602
Device Name ECLIPSE ICA BUN
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 Number862.1770
Classification Product Code
CDQ  
Date Received12/13/1990
Decision Date 01/16/1991
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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