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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Cholinesterase
510(k) Number K912148
Device Name CHOLINESTERASE 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 Number862.3240
Classification Product Code
DIH  
Date Received05/15/1991
Decision Date 08/12/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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