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510(k) K060619

DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A by Diazyme Laboratories — Product Code KHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2006
Date Received
March 8, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type

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