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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Albumin, Antigen, Antiserum, Control
510(k) Number K091486
Device Name K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR
Applicant
Kamiya Biomedical Co.
12779 Gateway Dr.
Tukwila,  WA  98168
Applicant Contact SHAWN KAPLAN
Correspondent
Kamiya Biomedical Co.
12779 Gateway Dr.
Tukwila,  WA  98168
Correspondent Contact SHAWN KAPLAN
Regulation Number866.5040
Classification Product Code
DCF  
Subsequent Product Code
JIT  
Date Received05/19/2009
Decision Date 04/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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