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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 K930488
Device Name BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST
Applicant
Syntron Bioresearch, Inc.
1080 Joshua Way
Vista,  CA  92083
Applicant Contact JAMES P LEE
Correspondent
Syntron Bioresearch, Inc.
1080 Joshua Way
Vista,  CA  92083
Correspondent Contact JAMES P LEE
Regulation Number862.1155
Classification Product Code
LCX  
Date Received01/29/1993
Decision Date 04/06/1993
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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