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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Platelet Factor 4 Radioimmunoassay
510(k) Number K890633
Device Name ENZYGNOST PLATELET FACTOR 4 (PF4) KIT
Applicant
BEHRING DIAGNOSTICS, INC.
17 CHUBB WAY
SOMERVILLE,  NJ  08876
Applicant Contact JOHN E HUGHES
Correspondent
BEHRING DIAGNOSTICS, INC.
17 CHUBB WAY
SOMERVILLE,  NJ  08876
Correspondent Contact JOHN E HUGHES
Regulation Number864.7695
Classification Product Code
LCO  
Date Received02/08/1989
Decision Date 04/21/1989
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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