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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K955353
Device Name ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT
Applicant
Tcpi, Inc.
3341 SW 15th St.
Pompano Beach,  FL  33069
Applicant Contact CLEVE W LAIRD
Correspondent
Tcpi, Inc.
3341 SW 15th St.
Pompano Beach,  FL  33069
Correspondent Contact CLEVE W LAIRD
Regulation Number862.1155
Classification Product Code
JHI  
Date Received11/21/1995
Decision Date 03/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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