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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
510(k) Number K990431
Device Name AIA-PACK CA 125
Applicant
Tosoh Medics, Inc.
347 Oyster Pt. Blvd.,
Suite 201
South San Francisco,  CA  94080
Applicant Contact JUDITH E LOEBEL
Correspondent
Tosoh Medics, Inc.
347 Oyster Pt. Blvd.,
Suite 201
South San Francisco,  CA  94080
Correspondent Contact JUDITH E LOEBEL
Regulation Number866.6010
Classification Product Code
LTK  
Date Received02/11/1999
Decision Date 06/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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