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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Antigen, Antiserum, Control
510(k) Number K042241
Device Name K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
Applicant
Kamiya Biomedical Co.
12779 Gateway Dr.
Tukwila,  WA  98168
Applicant Contact BRIAN SCHLIESMAN
Correspondent
Kamiya Biomedical Co.
12779 Gateway Dr.
Tukwila,  WA  98168
Correspondent Contact BRIAN SCHLIESMAN
Regulation Number866.5510
Classification Product Code
DGC  
Subsequent Product Code
JIT  
Date Received08/19/2004
Decision Date 12/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
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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