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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prealbumin, Fitc, Antigen, Antiserum, Control
510(k) Number K972812
Device Name RAICHEM PREALBUMIN SPIA
Applicant
Hemagen Diagnostics, Inc.
34-40 Bear Hill Rd.
Waltham,  MA  02154
Applicant Contact JOSEPH M CALIFANO
Correspondent
Hemagen Diagnostics, Inc.
34-40 Bear Hill Rd.
Waltham,  MA  02154
Correspondent Contact JOSEPH M CALIFANO
Regulation Number866.5060
Classification Product Code
DDS  
Date Received07/28/1997
Decision Date 08/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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