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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Estradiol
510(k) Number K853208
Device Name 125I ESTRADIOL DIRECT RADIOIMMUNOASSAY
Applicant
Travenol Laboratories, S.A.
600 Memorial Dr.
Cambridge,  MA  02139
Applicant Contact ROSA L DITUCCI
Correspondent
Travenol Laboratories, S.A.
600 Memorial Dr.
Cambridge,  MA  02139
Correspondent Contact ROSA L DITUCCI
Regulation Number862.1260
Classification Product Code
CHP  
Date Received07/31/1985
Decision Date 08/19/1985
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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