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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activated Partial Thromboplastin
510(k) Number K760318
Device Name ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT
Applicant
DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.7925
Classification Product Code
GFO  
Date Received07/26/1976
Decision Date 08/03/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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