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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 K874248
Device Name SYNTRON BIORESEARCH U-TEST PREGNANCY TEST
Applicant
Syntron Bioresearch, Inc.
4202 Sorrento Valley Blvd.
Suite G
San Diego,  CA  92121
Applicant Contact SHUNG-HO CHANG
Correspondent
Syntron Bioresearch, Inc.
4202 Sorrento Valley Blvd.
Suite G
San Diego,  CA  92121
Correspondent Contact SHUNG-HO CHANG
Regulation Number862.1155
Classification Product Code
LCX  
Date Received10/16/1987
Decision Date 11/04/1987
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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