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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 K960117
Device Name PLATFORM ONESTEP PREGNANCY HOME TEST
Applicant
Syntron Bioresearch, Inc.
2774 Loker Ave. W.
Carlsbad,  CA  92008
Applicant Contact CHARLES YU
Correspondent
Syntron Bioresearch, Inc.
2774 Loker Ave. W.
Carlsbad,  CA  92008
Correspondent Contact CHARLES YU
Regulation Number862.1155
Classification Product Code
LCX  
Date Received01/11/1996
Decision Date 03/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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