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510(k) K151487

Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method by Diatron U.S., Inc. — Product Code CFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2016
Date Received
June 2, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hexokinase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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