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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name test, leukocyte typing
510(k) Number K761008
Device Name LYMPHOCYTE TYPING, NEGATIVE CONTROL
Applicant
HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
803 N. Front St. Suite 3
mchenry,  IL  60050
Correspondent
HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
803 N. Front St. Suite 3
mchenry,  IL  60050
Regulation Number864.7675
Classification Product Code
LGO  
Date Received11/02/1976
Decision Date 04/06/1977
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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