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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, Human Chorionic Gonadotropin
510(k) Number K991515
Device Name INSURE PREGNANCY TEST
Applicant
Inbios Intl., Inc.
562 1st Ave. S, Suite 600
Seattle,  WA  98104
Applicant Contact ESTELA I RAYCHAUDHURI
Correspondent
Inbios Intl., Inc.
562 1st Ave. S, Suite 600
Seattle,  WA  98104
Correspondent Contact ESTELA I RAYCHAUDHURI
Regulation Number862.1155
Classification Product Code
DHA  
Date Received04/30/1999
Decision Date 05/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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