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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K885107
Device Name THROMBOSTIN IFA*
Applicant
Investigacion Farmaceutica S.A. DE C.V.
Calle 13-E # 5 Civac
Jiutepec, Morelos
Mexico,  MX
Applicant Contact JAMES SMITHERS
Correspondent
Investigacion Farmaceutica S.A. DE C.V.
Calle 13-E # 5 Civac
Jiutepec, Morelos
Mexico,  MX
Correspondent Contact JAMES SMITHERS
Regulation Number864.7750
Classification Product Code
GJS  
Date Received12/12/1988
Decision Date 06/23/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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