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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hexokinase, Glucose
510(k) Number K151487
Device Name Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method
Applicant
Diatron U.S., Inc.
2304 W 78th St.
Hialeah,  FL  33016
Applicant Contact Frank Matusazak
Correspondent
Ammirati Regulatory Consulting
575 Shirlynn Ct.
Los Angeles,  CA  94022
Correspondent Contact Erika B Ammirati
Regulation Number862.1345
Classification Product Code
CFR  
Subsequent Product Codes
CEM   CGZ   JGS   JJE  
Date Received06/02/2015
Decision Date 01/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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