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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixture, Hematology Quality Control
510(k) Number K851663
Device Name QUICK-COUNT HEMATOLOGY CONTROLS
Applicant
Seragen Diagnostics, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Applicant Contact MICHAEL J SULLVAN
Correspondent
Seragen Diagnostics, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Correspondent Contact MICHAEL J SULLVAN
Regulation Number864.8625
Classification Product Code
JPK  
Date Received04/23/1985
Decision Date 07/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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