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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Human Chorionic Gonadotropin
510(k) Number K883235
Device Name RAPIDTEST-HCG (TM)
Applicant
Synbiotics Corp.
11011 Via Frontera
San Diego,  CA  92127
Applicant Contact KENNETH L BERGER
Correspondent
Synbiotics Corp.
11011 Via Frontera
San Diego,  CA  92127
Correspondent Contact KENNETH L BERGER
Regulation Number862.1155
Classification Product Code
DHA  
Date Received08/01/1988
Decision Date 09/30/1988
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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