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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Immunological, Antigen, Tumor
510(k) Number K010796
Device Name AIA-PACK BRCA, ST AIA PACK BRCA
Applicant
TOSOH MEDICS, INC.
347 OYSTER POINT BLVD.,
SUITE 201
SAN FRANCISCO,  CA  94080
Applicant Contact LOIS NAKAYAMA
Correspondent
TOSOH MEDICS, INC.
347 OYSTER POINT BLVD.,
SUITE 201
SAN FRANCISCO,  CA  94080
Correspondent Contact LOIS NAKAYAMA
Regulation Number866.6010
Classification Product Code
MOI  
Date Received03/16/2001
Decision Date 08/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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