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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Factor Deficient
510(k) Number K972286
Device Name FACTOR DEFICIENT PLASMAS - FACTOR XI (11)
Applicant
Universal Reagents, Inc.
2858 N. Pennsylvania St.
Indianapolis,  IN  46205
Applicant Contact JORGE MILLER
Correspondent
Universal Reagents, Inc.
2858 N. Pennsylvania St.
Indianapolis,  IN  46205
Correspondent Contact JORGE MILLER
Regulation Number864.7290
Classification Product Code
GJT  
Subsequent Product Code
GGP  
Date Received06/19/1997
Decision Date 07/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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