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510(k) K053566

MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A by Diazyme Laboratories — Product Code MZV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2006
Date Received
December 22, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, System, Potassium, Enzymatic Method
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type

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