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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K950354
Device Name HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCY
Applicant
Ml Strategies, Inc.
One Financial Center
Boston,  MA  02111
Applicant Contact CAROLYN S LANGER
Correspondent
Ml Strategies, Inc.
One Financial Center
Boston,  MA  02111
Correspondent Contact CAROLYN S LANGER
Regulation Number862.1155
Classification Product Code
LCX  
Date Received01/30/1995
Decision Date 07/19/1995
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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