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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 K941765
Device Name HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE
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 Received03/25/1994
Decision Date 10/20/1994
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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