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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Luteinizing Hormone
510(k) Number K935134
Device Name ONE STEP LH TEST
Applicant
Tcpi, Inc.
P.O. Box 8726
Ft. Lauderdale,  FL  33310
Applicant Contact CLEVE W LAIRD, PH.D.
Correspondent
Tcpi, Inc.
P.O. Box 8726
Ft. Lauderdale,  FL  33310
Correspondent Contact CLEVE W LAIRD, PH.D.
Regulation Number862.1485
Classification Product Code
CEP  
Date Received10/28/1993
Decision Date 01/11/1994
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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