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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids
510(k) Number K993941
Device Name UBAS
Applicant
Marukin Diagnostics
3722 Ave., Sausalito
Irvine,  CA  92606
Applicant Contact GREG HOLLAND
Correspondent
Marukin Diagnostics
3722 Ave., Sausalito
Irvine,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number862.1187
Classification Product Code
KWX  
Date Received11/19/1999
Decision Date 03/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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