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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 K053566
Device Name MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A
Applicant
Diazyme Laboratories
3550 General Atomics Ct.
San Diego,  CA  92121
Applicant Contact HUAN TRAN
Correspondent
Diazyme Laboratories
3550 General Atomics Ct.
San Diego,  CA  92121
Correspondent Contact HUAN TRAN
Regulation Number862.1600
Classification Product Code
MZV  
Date Received12/22/2005
Decision Date 02/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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