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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
510(k) Number K944438
Device Name HEMAGEN CMV IGG KIT
Applicant
Hemagen Diagnostics, Inc.
34 Bear Hill Rd.
Waltham,  MA  02154
Applicant Contact JOSEPH M CALIFANO
Correspondent
Hemagen Diagnostics, Inc.
34 Bear Hill Rd.
Waltham,  MA  02154
Correspondent Contact JOSEPH M CALIFANO
Regulation Number866.3175
Classification Product Code
LFZ  
Date Received09/12/1994
Decision Date 02/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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