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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K882998
Device Name ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST
Applicant
Amtec Diagnostics International, Inc.
1107 Ih-45 S.
P.O. Box 2968
Conroe,  TX  77305
Applicant Contact HELEN JOHNSON
Correspondent
Amtec Diagnostics International, Inc.
1107 Ih-45 S.
P.O. Box 2968
Conroe,  TX  77305
Correspondent Contact HELEN JOHNSON
Regulation Number866.5270
Classification Product Code
DCK  
Date Received07/18/1988
Decision Date 09/07/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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