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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 K914155
Device Name TIA CRP TEST KIT
Applicant
Crestat Diagnostics, Inc.
22750
Hawthorne Blvd., Suite 206
Torrance,  CA  90505
Applicant Contact MIKE MUKAI
Correspondent
Crestat Diagnostics, Inc.
22750
Hawthorne Blvd., Suite 206
Torrance,  CA  90505
Correspondent Contact MIKE MUKAI
Regulation Number866.5270
Classification Product Code
DCK  
Date Received09/16/1991
Decision Date 01/15/1992
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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