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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 K934830
Device Name HCG PREGNANCY ONE STEP TEST STRIP
Applicant
Tcpi, Inc.
P.O. Box 8726
Ft. Lauderdale,  FL  33310
Applicant Contact CLEVE W LAIRD
Correspondent
Tcpi, Inc.
P.O. Box 8726
Ft. Lauderdale,  FL  33310
Correspondent Contact CLEVE W LAIRD
Regulation Number862.1155
Classification Product Code
LCX  
Date Received10/08/1993
Decision Date 12/02/1993
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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