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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K101741
Device Name DIATRON PICTUS 400
Applicant
Diatron Group
2545 Montclaire Cir.
Westo,  FL  33327
Applicant Contact JIM SCHEPP
Correspondent
Diatron Group
2545 Montclaire Cir.
Westo,  FL  33327
Correspondent Contact JIM SCHEPP
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
CEM   CGZ   JGS   JJE  
Date Received06/22/2010
Decision Date 01/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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