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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, System, Potassium, Enzymatic Method
510(k) Number K091455
Device Name DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL
Applicant
Diazyme Laboratories
12889 Gregg Ct.
Poway,  CA  92064
Applicant Contact Abhijit Datta
Correspondent
Diazyme Laboratories
12889 Gregg Ct.
Poway,  CA  92064
Correspondent Contact Abhijit Datta
Regulation Number862.1600
Classification Product Code
MZV  
Subsequent Product Codes
JIT   JJX  
Date Received05/18/2009
Decision Date 08/14/2009
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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