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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 K941090
Device Name UNISTEP HCG PREGNANCY TEST STRIP
Applicant
BIOTECH ATLANTIC, INC.
BAY F, 6 INDUSTRIAL WAY WEST
EATONTOWN,  NJ  07724
Applicant Contact YO YIH
Correspondent
BIOTECH ATLANTIC, INC.
BAY F, 6 INDUSTRIAL WAY WEST
EATONTOWN,  NJ  07724
Correspondent Contact YO YIH
Regulation Number862.1155
Classification Product Code
DHA  
Date Received03/08/1994
Decision Date 06/02/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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