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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 K013323
Device Name TCI-31 LIFELONG OVULATION TESTER
Applicant
Tci New York
575 Shirlynn Court
Los Angeles,  CA  94022
Applicant Contact Erika B Ammirati
Correspondent
Tci New York
575 Shirlynn Court
Los Angeles,  CA  94022
Correspondent Contact Erika B Ammirati
Regulation Number862.1485
Classification Product Code
CEP  
Date Received10/05/2001
Decision Date 12/05/2001
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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