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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 Immunosorbent Assay, T. Cruzi
510(k) Number K930272
Device Name HEMAGEN CHAGAS' KIT (EIA METHOD)
Applicant
Hemagen Diagnostics, Inc.
34 Bear Hill Rd.
Waltham,  MA  02154
Applicant Contact CHARLES A WILLAND
Correspondent
Hemagen Diagnostics, Inc.
34 Bear Hill Rd.
Waltham,  MA  02154
Correspondent Contact CHARLES A WILLAND
Regulation Number866.3870
Classification Product Code
MIU  
Date Received01/19/1993
Decision Date 05/19/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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