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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Groups, Streptococcus Spp.
510(k) Number K894122
Device Name LEECO VIS-DISK STREP-A (EIA)
Applicant
Leeco Diagnostics, Inc.
21705 Evergreen
P.O. Box 5126
Southfield,  MI  48075
Applicant Contact DANTE CAPALDI
Correspondent
Leeco Diagnostics, Inc.
21705 Evergreen
P.O. Box 5126
Southfield,  MI  48075
Correspondent Contact DANTE CAPALDI
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received06/12/1989
Decision Date 08/15/1989
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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