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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
510(k) Number K800916
Device Name P1 BLOOD GROUP SUBSTANCE
Applicant
Travenol Laboratories, S.A.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Travenol Laboratories, S.A.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.9160
Classification Product Code
KSX  
Date Received04/22/1980
Decision Date 05/08/1980
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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