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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K871308
Device Name ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT
Applicant
Allelix, Inc.
6850 Goreway Dr.
Mississauga, Ontario
Canada L4v 1p1,  CA
Applicant Contact JANET C SHAW
Correspondent
Allelix, Inc.
6850 Goreway Dr.
Mississauga, Ontario
Canada L4v 1p1,  CA
Correspondent Contact JANET C SHAW
Regulation Number862.1155
Classification Product Code
JHI  
Date Received04/01/1987
Decision Date 06/11/1987
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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