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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Cystatin C
510(k) Number K093137
Device Name K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
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 Number862.1225
Classification Product Code
NDY  
Subsequent Product Codes
JIT   JJX  
Date Received10/05/2009
Decision Date 09/28/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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